Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery (NCT03854929) | Clinical Trial Compass
CompletedPhase 4
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
Vietnam364 participantsStarted 2019-12-11
Plain-language 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.
Who can participate
Age range6 Months – 60 Months
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Assess the Clinical treatment failure between treatment groups.
Timeframe: after 120 hours of start of either treatment.
2
Assess the microbiological treatment failure between treatment groups.
Timeframe: after 72 hours of start of either treatment.
Trial details
NCT IDNCT03854929
SponsorOxford University Clinical Research Unit, Vietnam