Efficacy and safety of azithromycin for uncomplicated typhoid fever: an open label non-comparative study
Anju Aggarwal1, Apurba Ghosh, Sunil Gomber
1Department of Pediatrics, University College of Medical Sciences and Guru Tegh Bahadur Hospital, New Delhi, India.
Insights
Azithromycin effectively treated uncomplicated typhoid fever in children. The antibiotic demonstrated high clinical cure rates and was well-tolerated, showing it to be a safe and efficacious option.
Area of Science:
- Pediatric Infectious Diseases
- Antimicrobial Therapy
Background:
- Typhoid fever remains a significant public health concern, particularly in resource-limited settings.
- Effective and safe treatment options for pediatric typhoid fever are crucial for reducing morbidity and mortality.
Purpose of the Study:
- To evaluate the efficacy and safety of azithromycin for treating uncomplicated typhoid fever in children aged 2-12 years.
- To assess clinical and bacteriological cure rates and adverse events associated with azithromycin treatment.
Main Methods:
- An open-labelled, non-comparative study involving 117 children with uncomplicated typhoid fever.
- Azithromycin administered at 20mg/kg/day for 6 days.
- Clinical assessment and BACTEC blood cultures were used to determine outcomes.
Main Results:
- A clinical cure rate of 93.5% was observed in 102 children who completed the study.
- Bacteriological cure was achieved in all 17 patients with positive blood cultures for Salmonella typhi.
- No serious adverse events were reported, with good global well-being in 95% of cases.
Conclusions:
- Azithromycin is a safe and efficacious antibiotic for managing uncomplicated typhoid fever in children.
- The study supports the use of azithromycin as a viable treatment option for pediatric typhoid fever.
- Further research could explore azithromycin's role in multidrug-resistant typhoid strains.
Abstract:
An open-labelled, non-comparative study was conducted in 117 children aged 2-12 years to evaluate the efficacy and safety of azithromycin (20mg/ kg/day for 6 days) for the treatment of uncomplicated typhoid fever. Of the patients enrolled based on a clinical definition of typhoid fever, 109 (93.1%) completed the study.Mean (SD) of duration of fever at presentation was 9.1(4.5) days. Clinical cure was seen in 102 (93.5%) subjects, while 7 were withdrawn from the study because of clinical deterioration. Mean day of response was 3.45±1.97. BACTEC blood culture was positive for Salmonella typhi in 17/109 (15.5%) and all achieved bacteriological cure. No serious adverse event was observed. Global well being assessed by the investigator and subjects was good in 95% cases which was done at the end of the treatment. Azithromycin was found to be safe and efficacious for the management of uncomplicated typhoid fever.
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