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Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery

NCT03854929 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 364

Last updated 2023-06-07

No results posted yet for this study

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.

Conditions

  • Dysentery, Shigella
  • Shigellosis
  • Diarrhea

Interventions

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.

Sponsors & Collaborators

  • Number 2 Children's Hospital, Ho Chi Minh City

    collaborator OTHER

  • University of Liverpool

    collaborator OTHER

  • Oxford University Clinical Research Unit, Vietnam

    lead OTHER

Principal Investigators

  • Stephen Stephen, Professor · Oxford University Clinical Research Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
60 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-11
Primary Completion
2021-02-06
Completion
2022-07-12

Countries

  • Vietnam

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03854929 on ClinicalTrials.gov