Status:
COMPLETED
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
Lead Sponsor:
Oxford University Clinical Research Unit, Vietnam
Collaborating Sponsors:
Number 2 Children's Hospital, Ho Chi Minh City
University of Liverpool
Conditions:
Dysentery, Shigella
Shigellosis
Eligibility:
All Genders
6-60 years
Phase:
PHASE4
Brief 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 dysente...
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 ...
Eligibility Criteria
Inclusion
- Male or female aged 6 months to 60 months at time of hospital presentation.
- Have symptoms and/or signs of dysentery, specifically passing stools containing mucus and/or blood with/without abdominal pain, tenesmus or fever (≥37.8˚C).
- Be eligible for treatment with oral medication in the opinion of the admitting physician (i.e. no clinical requirement for parenteral treatment on admission).
- Be within 72 hours of the onset of signs/symptoms.
- Have a parent/guardian present at admission who can provide written informed consent.
Exclusion
- Those known to have specific medical (patients with known prolongation of the QT interval, congenital long QT syndrome)/surgical conditions which may affect disease severity/presentation or response to treatment (e.g. affecting antimicrobial absorption), including:
- gastrointestinal abnormalities, including short bowel syndrome, chronic (inflammatory or irritable) bowel disease.
- inherited or acquired immune system deficiency rendering the patient immunocompromised, including chronic/long-term steroid treatment or other immunosuppressive treatment
- Presentation with severe infection requiring parenteral antimicrobial treatment, including shock jaundice, extensive gastrointestinal bleeding, convulsion , drowsiness or coma, reduced or less movement when stimulated, tachypnea \> 60 times per minute, grunting, chest retraction, refuse to suck.
- Known hypersensitivity to any of the trial drugs (CIP or AZI).
- Coexisting infection requiring other or additional antimicrobials to be prescribed/ administered.
Key Trial Info
Start Date :
December 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2022
Estimated Enrollment :
364 Patients enrolled
Trial Details
Trial ID
NCT03854929
Start Date
December 11 2019
End Date
July 12 2022
Last Update
June 7 2023
Active Locations (1)
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1
Children's Hospital 2
Ho Chi Minh City, Vietnam, 70000