NCT04315272: GAMINII

Gut and Azithromycin Mechanisms in Infants and Children II

Completed Phase 4 Results posted Last updated 29 June 2023

What this trial tests

Phase 4 trial testing Azithromycin in Malaria in 449 participants. Completed in 1 June 2022.

Timeline

21 August 2020

Primary endpoint
1 June 2022

1 June 2022

Quick facts

Lead sponsor	University of California, San Francisco
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	449
Start date	21 August 2020
Primary completion	1 June 2022
Estimated completion	1 June 2022
Sites	1 location across Burkina Faso

Drugs / interventions tested

• Azithromycin (azithromycin) — full drug profile →
• Placebo

Conditions studied

• Malaria — all drugs for Malaria →

Sponsor

University of California, San Francisco

Who can join

Adults 8 Days to 59 Months, any sex, with Malaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Malaria Status Primary · 2 weeks

A rapid diagnostic test will be administered to all children to determine malaria status

Group	Value	95% CI
Azithromycin	18
Placebo	16

Clinical Malaria Secondary · 2 weeks

Clinical malaria will be defined by a positive rapid diagnostic test and fever.

Group	Value	95% CI
Azithromycin	6
Placebo	6

Adverse events — posted to ClinicalTrials.gov

Time frame: 14 days following azithromycin or placebo treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Azithromycin

Serious: 0/220 (0%)

Deaths: 0/220

Placebo

Serious: 0/227 (0%)

Deaths: 0/227

Other adverse events (5 terms — click to expand)

Reaction	System	Azithromycin	Placebo
Fever	General disorders	—	—
Diarrhea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Abdominal pain	General disorders	—	—
Constipation	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT04315272 adverse events section.

Sponsor's own description

Childhood mortality is decreasing worldwide. However, many sub-Saharan countries still have high children under 5 mortality rates. The MORDOR trial in Niger, Tanzania, and Malawi demonstrated a near 14% decrease in all-cause child mortality following biannual azithromycin in children 1-59 months. Current trials in Burkina aim to replicate these results from the MORDOR study with mass azithromycin treatment.

The investigators conducted an individually randomized placebo-controlled trial in Burkina Faso called the Gut and Azithromycin Mechanisms in Infants and Neonates Trial (GAMIN: NCT03676751) to evaluate the effect of a single dose of azithromycin (20 mg/kg) on potential mediators of the effect of azithromycin on all-cause mortality and to evaluate changes in the gut microbiome longitudinally (results pending). Here, the investigators propose to conduct an expansion of the original GAMIN trial. In GAMIN II, the investigators will evaluate 450 additional 1-59 month old children longitudinally for 6 months with a focus on stool collection and malaria status.

Objectives:

1\. To determine the effect of a single dose of azithromycin for children aged 8 days-59 months on malaria. The investigators hypothesize that a single dose of azithromycin will result in a reduced malaria status within the treatment group compared to the placebo group after a 14 day period within children ages 8 days-59 months.

The study will be conducted in Nouna Town in northwestern Burkina Faso.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Malaria positivity following a single oral dose of azithromycin among children in Burkina Faso: a randomized controlled trial.
   Brogdon J, Dah C, Sié A, Bountogo M, et al · · 2022 · cited 5× · PMID 35337289 · DOI 10.1186/s12879-022-07296-4