First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition (NCT03174236) | Clinical Trial Compass
UnknownPhase 3
First Line Antimicrobials in Children With Complicated Severe Acute Malnutrition
Kenya, Uganda2,000 participantsStarted 2017-09-04
Plain-language summary
Children with severe malnutrition who are admitted sick to hospitals have a high mortality(death rate), usually because of infection. All children with severe malnutrition admitted to hospitals are treated with antibiotics(medication used to kill bacteria). However, the current antibiotics used in hospitals may not be the most effective. It is possible that the antibiotics that are currently used after initial antibiotics should be used first. No studies have been carried out to determine if the current antibiotics used for treating malnourished children who are sick and admitted in hospital are the most appropriate. The aim of this study is to find out if a changed antibiotic system for children with malnutrition is safe, reduces the risk of death and improves nutritional recovery.
Who can participate
Age range
2 Months – 13 Years
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:
* Age 2 months to 13 years inclusive
* Severe malnutrition defined as:
* kwashiorkor at any age or:
* for children between 2 to 5 months: MUAC \<11cm or weight-for length Z score \<-3
* for children between 6 to 59 months: MUAC \<11.5cm or weight-for length Z score \<-3
* for children between 5 to 13 years: MUAC \<11.5cm or BMI-for-age Z score \<-3
* Admitted to hospital and eligible for intravenous antibiotics according to WHO guidelines
* Planning to remain within the hospital catchment area and willing to come for specified visits during the 90 day follow up period
* Informed consent provided by the parents/guardian
Exclusion:
* Known allergy or contraindication to penicillin, gentamicin, ceftriaxone or metronidazole
* A specific and documented clinical indication for another class of antibiotic
* Previously enrolled in this study
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.