Gut and Azithromycin Mechanisms in Infants and Children II

NCT04315272 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: OPP1187628-D
• Study Type: interventional
• Target: 449
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malaria

Outcome Measures

Primary Outcomes (1)

• Malaria Status

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

  2 weeks

Secondary Outcomes (1)

• Clinical Malaria

  2 weeks

Study Arms (2)

Azithromycin

ACTIVE COMPARATOR

A single dose of azithromycin will be administered to children between the ages of 8 days and 59 months old.

Drug: Azithromycin

Placebo

PLACEBO COMPARATOR

A single dose of placebo will be administered to children between the ages of 8 days and 59 months old.

Drug: Placebo

Interventions

Azithromycin DRUG

Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD\&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.

Also known as: Zithromax

Azithromycin

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 8 Days - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Between 8 days and 59 months old
• Primary residence within catchment area of study site
• Available for full 6 month study
• No known allergy to macrolides/azalides
• Appropriate written informed consent from at least one parent or guardian
• Able to feed orally

You may not qualify if:

• \<8 days old or \>59 months
• Primary residence outside catchment area of study site
• Not available for full 6 month study
• Known allergy to macrolides/azalides
• No written informed consent from at least one parent or guardian
• Unable to feed orally

Sponsors & Collaborators

• University of California, San Francisco: lead
• Centre de Recherche en Sante de Nouna, Burkina Faso: collaborator

Study Sites (1)

Centre de Recherche en santé de nouna

Nouna, Boucle du Mouhoun, Burkina Faso

Location

Related Publications (1)

• Brogdon J, Dah C, Sie A, Bountogo M, Coulibaly B, Kouanda I, Ouattara M, Compaore G, Nebie E, Seynou M, Lebas E, Nyatigo F, Hu H, Arnold BF, Lietman TM, Oldenburg CE. Malaria positivity following a single oral dose of azithromycin among children in Burkina Faso: a randomized controlled trial. BMC Infect Dis. 2022 Mar 25;22(1):285. doi: 10.1186/s12879-022-07296-4.

  PMID: 35337289 DERIVED

MeSH Terms

Conditions

Malaria

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals

Results Point of Contact

• Title: Dr Catherine Oldenburg
• Organization: UCSF FI Proctor Foundation

catherine.oldenburg@ucsf.edu

(415) 502-8843

Study Officials

• Catie Oldenburg, ScD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple: (Participant, Care Provider, Investigator, Outcomes Assessor)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Individually randomized placebo-controlled trial of azithromycin vs. placebo to establish the efficacy and safety of azithromycin.

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 19, 2020
• Study Start: August 21, 2020
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: June 29, 2023
• Results First Posted: June 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)