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 range
6 Months – 60 Months
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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.