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New treatment option for Malnutrition, Child
Official title Azithromycin as Adjunctive Treatment for Uncomplicated Severe Acute Malnutrition
ClinicalTrials.gov ID: NCT06010719
What this study is testing
What is Azithromycin?
Azithromycin is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for malnutrition, child.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Amoxicillin is recommended by the World Health Organization (WHO) as adjunctive therapy for the treatment of uncomplicated severe acute malnutrition (SAM). Because children with uncomplicated SAM may have asymptomatic infection due to immune suppression, presumptive treatment with a broad-spectrum antibiotic may be beneficial by clearing any existing infection and improving outcomes.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 59
You may be able to join if
- Children with uncomplicated SAM per Burkina Faso's national guidelines who present to an eligible enrollment site during the study period and meet...
- Age 6-59 months
- WHZ\<-3 SD or MUAC\<115 mm
- Primary residence within a catchment area of an enrollment site
- Available for full 8-week study (primary endpoint)
You likely can't join if
- Age less than 6 month or more than 59 months
- WHZ\>-3 SD or MUAC\>115 mm
- Primary residence is not within a catchment area of an enrollment site
- Not Available for full 8-week study (primary endpoint)
- Admitted to a nutritional program for SAM treatment in the previous 2 weeks
- Edema
See the full eligibility criteria
- Children with uncomplicated SAM per Burkina Faso's national guidelines who present to an eligible enrollment site during the study period and meet all of the eligibility criteria below will be considered for enrollment:
- Age 6-59 months
- WHZ\<-3 SD or MUAC\<115 mm
- Primary residence within a catchment area of an enrollment site
- Available for full 8-week study (primary endpoint)
- Not admitted to a nutritional program for SAM treatment in the previous 2 weeks
- No edema
- No antibiotic use in the past 7 days
- No clinical complications requiring antibiotic or inpatient treatment\ \
- No congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease...
- No known allergies to macrolides/azalides or amoxicillin/penicillin
- Sufficient appetite according to a feeding test with RUTF
- Written informed consent from at least one parent or guardian
- Age less than 6 month or more than 59 months
- WHZ\>-3 SD or MUAC\>115 mm
- Primary residence is not within a catchment area of an enrollment site
- Not Available for full 8-week study (primary endpoint)
- Admitted to a nutritional program for SAM treatment in the previous 2 weeks
- Edema
- Antibiotic use in the past 7 days
- Clinical complications requiring antibiotic or inpatient treatment\ \
- Congenital abnormality or chronic debilitating illness that would lead to predictable growth faltering or reduce likelihood of SAM treatment benefit (such as cerebral palsy, Down syndrome, congenital heart disease...
- Known allergies to macrolides/azalides or amoxicillin/penicillin
- No Sufficient appetite according to a feeding test with RUTF
- No Written informed consent from at least one parent or guardian
- Per Burkinabé guidelines, children any of the following conditions will not be eligible for the trial and will be referred to an inpatient facility: MUAC \<115 mm with complications; MUAC \<115 mm plus edema; bipedal...
The study team makes the final eligibility decision.
Where it's taking place
- Nouna, Kossi, Burkina Faso
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 months to 59 months. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nouna, Kossi, Burkina Faso. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.