NCT03854929

Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

An Open Label Randomised Controlled Trial of Azithromycin Versus Ciprofloxacin for the Treatment of Children Hospitalised With Dysentery in Ho Chi Minh City, Vietnam

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 364 (actual)
• Sponsor: Oxford University Clinical Research Unit, Vietnam · Academic / Other
• Sex: All
• Age: 6 Months – 60 Months
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy of 3 days of azithromycin (AZI) compared to 3 days of ciprofloxacin (CIP) (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City.

Detailed description

Antimicrobial resistance is a well-established international healthcare crisis and children with diarrhoeal infections represent a significant proportion of the global infectious disease burden. With the increasing rates of antimicrobial resistance observed in the organisms associated with children presenting with dysentery in Vietnam and the investigator's capacity to demonstrate international transmission events, new data regarding alternative treatment options such as azithromycin, in particular for the new highly-antimicrobial resistant S. sonnei, are urgently needed. The study team will perform a phase IV open label randomised controlled trial to compare the efficacy of AZI to CIP (standard-of-care) for the treatment of children hospitalised with dysentery in Ho Chi Minh City, Vietnam. Children aged 6 to 60 months presenting to the participating hospital with symptoms/signs of dysentery (diarrhoea with blood and/or mucus accompanied by 1 or more of: fever ≥37.8°C, abdominal pain and /or tenesmus) within the previous 72 hours will be enrolled to the study. After enrolment, participants will be managed according to WHO and local algorithms for children with bloody diarrhoea. In addition, after providing a stool sample, children will be randomly allocated to receive CIP 15mg/kg body weight/ twice daily or AZI 10mg/kg body weight/ daily for 3 days. After enrolment, children will be reviewed for clinical and microbiological response to treatment.

Conditions

• Dysentery, Shigella
• Shigellosis
• Diarrhea

Interventions

Type	Name	Description
DRUG	Ciprofloxacin	Fluoroquinolone, ATC code: J01MA02 DNA-gyrase and topoisomerase IV inhibitor
DRUG	Azithromycin	Macrolide, ATC code: J01FA10 Binds to ribosomal 50S sub-unit inhibiting translocation of peptides thereby suppressing bacterial protein synthesis.

Timeline

• Start date: 2019-12-11
• Primary completion: 2021-02-06
• Completion: 2022-07-12
• First posted: 2019-02-26
• Last updated: 2023-06-07

Locations

1 site across 1 country: Vietnam