Antibiotic Utilization and Comparative Study of Therapies in Lower respiratory Tract Infections among Pediatrics in Tertiary care Hospitals

Noopur Shewale, Rohini Vighne, Anuja Vaidya, Soyab Shaikh, Dr. Trupti Tuse, Gopal Sharma,

doi:10.5281/zenodo.15458575

Research Paper | Open Access
Volume 03 | Issue 05 | Article Id IJPS/250305025

Antibiotic Utilization and Comparative Study of Therapies in Lower respiratory Tract Infections among Pediatrics in Tertiary care Hospitals
Noopur Shewale* Rohini Vighne Anuja Vaidya Soyab Shaikh Dr. Trupti Tuse Gopal Sharma
Abhinav Education Society’s College of Pharmacy, Narhe, Pune 411041.

Abstract

Aim: This study aims to assess the utilization of Antibiotics and compare the therapies in Lower respiratory tract infections among Paediatrics in Tertiary care hospitals. Methodology: This Prospective, observational study was conducted in the Pediatric Department of A tertiary care hospital for over 6 months. The patient profile sheets analyzed the Data of Pediatric patients diagnosed with lower respiratory tract infections (LRTI). Result: A total of 152 pediatric patients were evaluated, in which male predominance was seen by 55.92% followed by female 44.07%. Pneumonia was the most common condition (81.57%) of the total pediatric patients, most of the subjects were from the age group 4-7 years accounted for 38.15% of total pediatric population. Monotherapy was preferred in 61.18% of patients, who had a shorter hospital stay compared to dual therapy and polytherapy. Conclusion: The study revealed the predominant use of ?-lactam antibiotic (Ceftriaxone) as well as the most preferred combination therapy was ?-lactam + Glycopeptide antibiotic (Vancomycin). A positive trend towards monotherapy was observed. These findings can guide the development of evidence-based treatment protocols for LRTI in paediatrics.

Keywords

LRTI, Paediatric, Antibiotic, Drug Utilization Evaluation, Antimicrobials

Introduction

Lower respiratory tract infections (LRTIs) continue to pose a major public health concern globally, particularly in children under the age of five. These infections—primarily pneumonia, bronchiolitis, and bronchitis—are among the leading causes of paediatric morbidity and mortality, accounting for a significant proportion of hospital admissions and deaths worldwide.^1-2 The burden is especially high in developing countries like India, where overcrowding, malnutrition, poor air quality, and limited access to timely healthcare further exacerbate the incidence and severity of LRTIs.^3-5Antibiotics remain the cornerstone of treatment for LRTIs, even though many of these infections may have viral etiologist. Inappropriate antibiotic prescribing, including the use of broad-spectrum agents in mild or self-limiting infections, contributes substantially to the growing global threat of antimicrobial resistance (AMR).^6-7 According to the World Health Organization (WHO), India ranks among the highest in antibiotic consumption, and irrational use in paediatric populations is a contributing factor to the alarming rise in drug-resistant infections.^8-9In paediatric practice, the choice of therapy often lies between monotherapy and combination (dual or poly) therapy. Monotherapy, involving a single antibiotic, is generally preferred due to its simplicity, cost-effectiveness, and lower risk of adverse effects or resistance development. However, combination therapies are frequently used empirically in hospital settings, particularly when clinicians suspect mixed infections, resistance, or severe clinical presentation. Despite widespread use, the evidence comparing the effectiveness and rationality of monotherapy versus combination therapy in paediatric LRTIs remains limited.¹

Mono-Therapy	Poly-Therapy
Monotherapy reduces the risk of antibiotic resistance development.	Empirical treatment where the specific etiology of infection is uncertain.
Simplifies the treatment regimen and reduces the complexity of the dosing schedule	Combination therapy for synergistic effect
Targeted action leading to effective eradication of pathogens	Treatment of mixed infection using multiple antibiotics concurrently increases the spectrum of coverage, ensuring that a wider range of bacterial pathogens causing the infection are targeted effectively.
Easier monitoring of efficacy	This approach may be beneficial in cases where the causative pathogen is suspected to be resistant to a single antibiotic.

The duration of treatment in paediatric patients receiving antibiotics can vary significantly between monotherapy and polytherapy, particularly in the context of lower respiratory tract infections (LRTIs).

Another important consideration in paediatric pharmacotherapy is weight-based dosing. Inaccurate dose calculations can compromise treatment efficacy or increase toxicity risk. Hence, rational prescribing must account for drug selection, dose accuracy, duration of treatment, and adherence to established guidelines. Evaluating these parameters in real-world settings is crucial for optimizing outcomes and supporting antibiotic stewardship initiatives.^11-12This study was conducted to assess antibiotic utilization patterns and compare the therapeutic outcomes of monotherapy versus combination therapy in paediatric patients diagnosed with LRTIs in a tertiary care hospital. Additionally, the study evaluates prescribing rationality using standard criteria to highlight areas for improvement in clinical practice. The findings aim to contribute to the development of evidence-based guidelines for managing paediatric LRTIs more effectively.^13-15

METHODOLOGY

Study Design

This was a prospective, observational study designed to assess antibiotic utilization patterns and compare therapeutic outcomes in paediatric patients with lower respiratory tract infections (LRTIs).

Setting and Duration

The study was conducted in the Paediatrics Department of a tertiary care hospital located in an urban area of India. Data collection spanned a period of six months, from October 2023 to March 2024.

Sample Size Calculation

The sample size was determined using Slovin’s formula:

n = N1+Ne2

Assuming an estimated paediatric LRTI patient population of 250 over six months and a 5% margin of error (e = 0.05):

n = 2501+250(0.05)2

= 2501+0.625

=152

Thus, 152 paediatric patients were enrolled, providing adequate representation for descriptive statistical analysis.

Inclusion and Exclusion Criteria

Inclusion Criteria:

Children aged <15 years.
Diagnosed with LRTI (e.g., pneumonia, bronchiolitis, bronchitis, WALRI).
Prescribed at least one systemic antibiotic during hospitalization.

Exclusion Criteria:

Patients with upper respiratory tract infections (URTIs).
Incomplete or missing medical records.
Children who were discharged or transferred before completing antibiotic therapy.

Data Collection Tools

Data were extracted using a structured Patient Profile Sheet, which included the following:

Demographic data: age, gender, body weight.
Diagnosis details and laboratory investigations.
Antibiotic therapy: name, dose (mg/kg), route, frequency, duration.
Hospital stay duration.
Dosage appropriateness as per paediatric guidelines.
Microbiological panel results (if available).

Ethical Approval

The study protocol was reviewed and approved by the Institutional Ethics Committee (IEC) of the participating hospital. All data were anonymized to ensure patient confidentiality, and no identifiable information was used.

Statistical Analysis

All collected data were entered in Microsoft Excel and analyzed using descriptive statistics. Categorical variables (e.g., gender, diagnosis, antibiotic class) were summarized as frequencies and percentages. Continuous variables (e.g., age, duration of hospital stay) were reported as means with standard deviations (mean ± SD). Compliance to weight-based antibiotic dosing was also evaluated.

RESULT

A total of 152 paediatric inpatients diagnosed with LRTIs were included in the study. Among them, 85 (55.92%) were male and 67 (44.07%) were female. The most affected age group was 4–7 years (58 patients; 38.15%), followed by 1–3 years (45; 29.60%) and 0–1 year (31; 20.39%).

Fig.6.1: Number of patients

Fig. 6.2: Patients Diagnosis

The diagnostic distribution revealed that majority of subjects were suffering from Pneumonia [124(81.57%)], followed by WALRI which was the second most leading infectious disease which was about [18(11.84%)], then bronchiolitis in [9(5.92%)] and bronchitis in [1(0.65%)].

Fig. 6.3: Age-Wise Patient Classification

In total 152 paediatric inpatients most of the subjects were from the age group of 4 -7 years old [58(38.15%)] followed by the toddlers of age 1-3 years [45(29.60%)], infants of 0 -1 years [31(20.39%)], children of 8 -11 years [13(8.55%)] and 12-15 years [5(3.2%)].

Fig.6.4: Age Wise Diagnostic Distribution

The study revealed that the most common diagnosis among the paediatric population was pneumonia. Age Distribution of Patients who were diagnosed with Pneumonia:

17 (11.81%) patients were from the age group 0–1 year.
53 (34.8%) patients were from the age group 1–3 years.
30 (19.73%) patients were from the age group 3–5 years.
26 (17.10%) patients were from the age group 6–10 years.
5 (3.2%) patients were from the age group 11–14 years.

Patients Diagnosed with Bronchiolitis:

All 8 (5.26%) patients were from the age group 0–1 year.

Patients Diagnosed with WALRI:

3 (1.97%) patients were from the age group 0–1 year.
8 (5.26%) patients were from the age group 1–3 years.
2 (1.31%) patients were from the age group 3–5 years.
4 (2.63%) patients were from the age group 6–10 years.

Fig. 6.5: Microbes Identified in Panel Test

54 (35.5%) out of 152 paediatric patients had a pneumonia panel, which was carried out during diagnosis. Gram-positive bacterial strains streptococcus pneumoniae [15(27.77%)] and Staphylococcus aureus [5(9.2%)] were found to be more prevalent in respiratory tract cultures than Gram-negative bacterial strains Moraxella catarrhalis [5(9.2%)] and Haemophilus influenza [4(7.4%)]. Adenovirus was the dominant pathogen in cause of viral LRTI [20(37.03%)], followed by Influenza A virus [7(12.96%)], Rhinovirus a positive-sense, single stranded RNA in [6(11.11%)], H1N1 virus [5(9.2%)], Human metapneumovirus [4(7.4%)], Parainfluenza virus [3(5.5%)], Bocavirus [2(3.7%)], Respiratory syncytial virus [1(1.85%)]. Pneumonia Panel Test was done in 35.5% of the cases of pneumonia. Among those panel tests, the frequency of gram-positive bacterial strains Streptococcus pneumoniae was 27.77% and Staphylococcus aureus was 9.2%, which was higher than gram-negative bacterial strains like Moraxella catarrhalis 9.2% and Haemophilus influenzae 7.4%. A study conducted by Naik H. G. et.al had 33.33 % culture present in which 13.04% coagulase staphylococci and 4.34% streptococci was isolated. Adenovirus was the dominant pathogen in causing viral LRTI 37.03%, then followed by Influenza A virus in about 12.96%, then Rhinovirus a positive-sense, single stranded RNA in 11.11%, H1N1 virus 9.2%, Human metapneumovirus 7.4%, Parainfluenza virus 5.5%, Bocavirus 3.7%, Respiratory syncytial virus 1.85%. In Blacklaw N. R. et.al,^[59] in his study has observed that over 60 different adenovirus serotypes have been identified. The diversity of serotypes contributes to the prevalence of adenovirus LRTIs in children. There are no specific antiviral treatments or vaccines for adenovirus infections in children; this leaves children vulnerable to severe adenovirus LRTIs.

Table No 1: Drug Prescribing Patterns:

Parameter	Number/Percentage
Total number of patient prescription analysed	152
Total number of drugs prescribed	891
Average number of drugs per prescription	5.86
% of prescriptions with oral antibiotics prescribed	8.05%
% of prescriptions with an injection prescribed	26.1%

Fig. 6.6: Antibiotic Distribution

The presented data reveals the individual antibiotic use in paediatric inpatients, with Ceftriaxone being the most prescribed antibiotic in the paediatric population [152(65.51%)]. The other antibiotics were used in combination with ceftriaxone to achieve synergistic effect or in case where ceftriaxone was unable to eradicate fever thus, the sequence follows as vancomycin [43(18.53%)], azithromycin [15(6.46%)], Meropenem [10(4.31%)], Amikacin [5(2.15%)], Linezolid [4(1.72%)], Piperacillin and tazobactam [3(1.29%)], Cefuroxime [1(0.6%)], Cefixime [1(0.4%)], Cefazoline [1(0.4%)], Doxycycline [1(0.4%)].

Fig.6.7: Percentage Of Major Drug Class Used

In the study, the other major classes of drug prescription along with the antibiotics were also analysed. Accordingly, the most commonly used drugs were antiemetics (17.05%), antibacterials (32.1%), bronchodilators (20.81%), antiviral (19.45%), antipyretics (16.32%), steroids (5.98%), cough medication (3.40%) and nasal decongestants (2.53%).

Fig.6.8: Pattern use of antibiotics

Prescribing pattern of antibiotics	Number of Patients (n)	Percentage (%)	Common Antibiotics
Monotherapy	93	61.18	Ceftriaxone
Dual Therapy	42	27.63	Ceftriaxone, Vancomycin, Meropenem, Piperacillin-Tazobactam, Amikacin, Cefuroxime, Linezolid, Azithromycin
Polytherapy	17	11.18	Ceftriaxone, Vancomycin, Meropenem, Piperacillin-Tazobactam, Amikacin, Cefuroxime, Linezolid, Azithromycin

Fig.6.9: Dose Accuracy Graph

In the study, dosage accuracy with respect to standard treatment-related guidelines was also studied in the entire study population by calculating the antibiotic dosage (mg/kg/dose) in relation to individual patients' weight. Thus, therapy-wise compliance was seen as follows-

Monotherapy- In total, [93(61.18%)] patients received monotherapy in which [71(76.34%)] showed compliance when standard dose was calculated for the weight of individual.

Dualtherapy- [42(27.63%)] patients received dual therapy in which [31(73.8%)] showed compliance.

Polytherapy- [17(11.18%)] patients received polytherapy in which [13(76.47%)] showed compliance.

Fig.6.10: Average Number of Days of Hospitalization

The efficacy of the treatment was determined based upon the number of days of hospitalization for a particular type of therapy, either Children receiving only beta-lactam monotherapy or a combination of beta-lactam and glycopeptide dual therapy depending upon the final diagnosis of the particular patients. The study evaluated the efficacy of β-lactam monotherapy versus β-lactam + glycopeptide combination therapy based on hospitalization

1. Pneumonia

Ceftriaxone (Monotherapy): Administered to 73 patients (43.97%), with a mean hospitalization duration of 4.02 ± 1.40 days.
Ceftriaxone + Vancomycin (Combination Therapy): Administered to 22 patients (18.96%), with a mean hospitalization duration of 5.9 ± 2.52 days.

2. Wheezing-Associated Lower Respiratory Tract Infection (WALRI)

Ceftriaxone (Monotherapy): Administered to 8 patients (6.89%), with a mean hospitalization duration of 3.8 ± 1.55 days.
Ceftriaxone + Vancomycin (Combination Therapy): Administered to 4 patients (3.44%), with a mean hospitalization duration of 5.7 ± 2.06 days.

3. Bronchiolitis

Ceftriaxone (Monotherapy): Administered to 5 patients (4.31%), with a mean hospitalization duration of 3.6 ± 1.51 days.
Ceftriaxone + Vancomycin (Combination Therapy): Administered to 4 patients (3.44%), with a mean hospitalization duration of 7.3 ± 5.50 days.

The mean duration of hospitalization was shorter for patients receiving Monotherapy compared to those receiving Dual or Polytherapy. The rationality of the anti-microbials prescribed was analysed by Modified Kunin’s rationality criteria:

Category 1: Agree with the use of antimicrobial therapy; the protocol is appropriate	109 (71.7%)
Category 2: Agree with the use of antimicrobial therapy; the protocol is appropriate, but a microbiology report is missing to classify the protocol in another category	14 (9.2%)
Category 3: Agree with the use of antimicrobial therapy, but a different antimicrobial is preferred	23 (15.13%)
Category 4: Agree with the use of antimicrobial therapy but a modified dose, interval, duration, or route of administration is preferred	4 (2.63%)
Category 5: Disagree with the use of antimicrobial therapy; the administration is unjustified	2 (1.31%)

DISCUSSION

This prospective observational study analyzed the data of 152 paediatric patients diagnosed with lower respiratory tract infections (LRTIs) in the paediatric department of a tertiary care hospital. The study revealed a male predominance, with 85 males (55.92%) and 67 females (44.07%), which aligns with findings from other studies such as those by T. Chaitanya et al. (60.8% males) and V.K. Munagala et al. (65.33% male predominance). This male preponderance could be attributed to factors like an underdeveloped immune system in males, as well as potential genetic differences that may influence susceptibility to infections. Regarding age distribution, the highest incidence of LRTIs was observed in the 4–7 years age group (38.15%), followed by 1–3 years (29.60%) and 0–1 year (20.39%). The lowest prevalence occurred in children 12–15 years old (3.2%), a trend consistent with studies by Khan M.A et al., which noted a high prevalence in children ≤6 months, and Dr. Shivleela et al., which identified 46.12% of cases in the 0–1 year age group. LRTI severity tends to decrease with age, and children over 10 years generally experience lower rates of incidence. These findings suggest that younger children, particularly those under 5 years, are more vulnerable due to their immature immune systems, smaller airways, and higher exposure to environmental risk factors like second-hand smoke and air pollution. Pneumonia emerged as the most common diagnosis, with 124 cases (81.57%), predominantly in children aged 1–3 years (34.8%). This aligns with findings from Wardlaw et al., who also found the highest incidence of pneumonia in children under 5 years. Wheezing-associated LRTI (WALRI) was the second most common, affecting 18 children (11.84%), and bronchiolitis followed closely with 9 cases (5.92%), all occurring in infants under 1 year. The least prevalent condition was bronchitis, identified in only 1 patient (0.65%). In terms of treatment, 891 medications were prescribed across 152 prescriptions, yielding an average of 5.86 ± 2.42 drugs per prescription. This is notably higher than findings from T. Rajavardhana et al., where the average was just 2.15 drugs per prescription. Ideally, the number of drugs per prescription should be kept to a minimum to avoid polypharmacy-related risks, such as drug interactions, non-compliance, and increased healthcare costs. The World Health Organization (WHO) recommends limiting the number of medications to under two, highlighting the importance of minimizing polypharmacy. The primary goal in the treatment of LRTIs in general practice is to treat patients with as much accuracy as possible, employing an empirical therapeutic approach. The present study shows the overall patterns of antibiotic use in the paediatric inpatient department for LRTIs. The most commonly prescribed antibiotic in this study was ceftriaxone, a third-generation cephalosporin, used in 65.51% of cases. This is consistent with other studies, such as that by Suwitha S. and Suriya P., where cefotaxime, another third-generation cephalosporin, was the most prescribed. Vancomycin was prescribed in 18.53% of cases, usually in combination with ceftriaxone or meropenem to treat methicillin-resistant Staphylococcus aureus (MRSA) or other multidrug-resistant organisms (MDROs). Regarding the types of antibiotic therapies, monotherapy was the most common, used in 93 patients (61.18%), followed by dual therapy in 42 patients (27.63%) and polytherapy in 17 patients (11.18%). These findings are consistent with the study by Patil T. et al., while a contrasting trend was observed in the study by Hemamalini M.B., where dual and polytherapy were more frequently used than monotherapy.

Table no. 7.1: Combination Therapy of Antibiotics in Pneumonia

Combination Of Antibiotics	No. of Patients (%)
Ceftriaxone	77(50.65%)
Ceftriaxone + Vancomycin	24(15.78%)
Ceftriaxone + Vancomycin + Meropenem	7(4.6%)
Ceftriaxone + Azithromycin	8(5.26%)
Ceftriaxone + Vancomycin + Azithromycin	3(1.97%)
Ceftriaxone + Piperacillin & Tazobactam	2(1.31%)
Ceftriaxone + Meropenem + Vancomycin + Linezolid	1(0.67%)
Ceftriaxone + Vancomycin + Linezolid+ Azithromycin + Cefixime	1(0.67%)
Ceftriaxone + Vancomycin + Linezolid	1(0.67%)
Amikacin + Piperacillin & Tazobactam	1(0.67%)

Table no.7.2: Combination Therapy of Antibiotics in Walri

Combination Of Antibiotics	No. of Patients (%)
Ceftriaxone	9(5.92%)
Ceftriaxone + Vancomycin	4(2.63%)
Ceftriaxone + Azithromycin	3(1.97%)
Ceftriaxone + Cefpodoxime	1(1.97%)

Table no. 7.3: Combination Therapy of Antibiotics in Bronchiolitis

Combination Of Antibiotics	No. of Patients (%)
Ceftriaxone	5(3.28%)
Ceftriaxone + Vancomycin	2(1.31%)
Ceftriaxone + Vancomycin + Azithromycin	1(0.67%)

Our study analysed antibiotic dosing accuracy concerning standard treatment guidelines based on individual patient weight for the sake of safety and efficacy, weight-based dosing method is needed for particular population. In Monotherapy Out of 93 patients receiving monotherapy, 71 (76.34%) showed accuracy with the standard dose calculated based on their weight, while 22 (23.65%) did not comply due to receiving a lower dose of ceftriaxone than needed for their respective weight, in Dual therapy Among 42 patients, 31 (73.8%) showed accuracy, while 11 (26.19%) were inappropriate. In the case of 17 patients receiving polytherapy, 13 (76.47%) showed accuracy and 4 (23.52%) were inappropriate. In our study the rationality of Anti microbials prescribed was also analysed by using Modified Kunin’s Rationality Criteria. Appropriate therapy was given in 109 cases (71.7%) which were classified under Category I, meanwhile 14(9.2%) cases were under Category II, followed by Category III with 23(15.13%) cases where different antimicrobial was prescribed of the same class i.e. instead of ceftriaxone either cefuroxime or cefazoline. Similar result was observed in a study conducted by Chadva S.A et.al.^[64] The rationality of the AMAs prescribed was also analysed by modified Kunin’s rationality criteria. Appropriate therapy was given in 68.93% of patients, and 71 cases were classified under Category-I i.e. agree with the use of antimicrobial therapy, the protocol is appropriate. Despite the valuable insights provided, the study's limitations include its single-center design and relatively small sample size. Future studies with larger, multi-center cohorts are recommended to validate these findings and explore additional factors influencing antibiotic use and treatment outcomes in paediatric LRTI.

CONCLUSION

This study demonstrated that lower respiratory tract infections (LRTIs) in paediatric inpatients were most prevalent among children aged 1–7 years, with pneumonia being the leading diagnosis (81.57%). The antibiotic ceftriaxone, a third-generation cephalosporin, was the most commonly prescribed agent, reflecting its broad-spectrum efficacy and paediatric tolerability. Notably, monotherapy was utilized in 61.18% of cases, with over 76% of these doses adhering to weight-based standards, highlighting an encouraging trend toward rational antibiotic use. According to the Modified Kunin’s Criteria, 71.7% of prescriptions were deemed appropriate (Category I), indicating a generally evidence-aligned prescribing pattern. These findings suggest that adherence to treatment guidelines and preference for monotherapy may help mitigate the risks of polypharmacy, antimicrobial resistance, and adverse drug interactions. The study underscores the need for strengthened antibiotic stewardship programs in paediatric care, including regular audits, prescriber education, and the implementation of hospital-specific LRTI management protocols. Future multicentric studies with larger cohorts are recommended to generalize these findings and further inform optimal antibiotic strategies in paediatric respiratory infections.

ACKNOWLEDGEMENT

I would like to express my sincere gratitude to my supervisor, Dr. Shital Dhawane, for his guidance and support throughout this research. I am also thankful to Abhinav Education Society College of Pharmacy, Pune for their assistance and cooperation.

Conflict Of Interest

The authors declare that there is no conflict of interest.

Summary Of the Study Findings

The study analyzed antibiotic utilization and treatment patterns in 152 paediatric patients diagnosed with lower respiratory tract infections (LRTIs) in a tertiary care hospital. A male predominance (55.92%) was observed, with pneumonia being the most prevalent condition (81.57%), followed by WALRI (11.84%), bronchiolitis (5.92%), and bronchitis (0.65%). The most affected age group was 4-7 years (38.15%). Among the microbial findings, Gram-positive bacteria, particularly Streptococcus pneumoniae (27.77%) and Staphylococcus aureus (9.2%), were more prevalent than Gram-negative strains like Moraxella catarrhalis (9.2%) and Haemophilus influenzae (7.4%). Adenovirus was the dominant viral pathogen (37.03%), followed by Influenza A (12.96%) and Rhinovirus (11.11%). Antibiotic utilization patterns showed a preference for monotherapy (61.18%), primarily with Ceftriaxone (65.51%), whereas dual therapy (27.63%) and polytherapy (11.18%) were less common. Hospitalization duration was shorter for patients receiving monotherapy compared to those on combination therapies, with Ceftriaxone monotherapy leading to an average hospital stay of 4.02 ± 1.40 days for pneumonia patients, while dual therapy (Ceftriaxone + Vancomycin) resulted in 5.9 ± 2.52 days. The study also evaluated the rationality of antibiotic prescriptions using Modified Kunin’s Rationality Criteria, with 71.7% classified as appropriate, highlighting a trend toward evidence-based prescribing practices.

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