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A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

NCT02211729 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 22090

Last updated 2018-03-07

No results posted yet for this study

Summary

The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ.

This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season.

Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded.

Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period

Secondary endpoints:

1. incidence of the primary endpoint during the whole study period
2. attendance at a study health centre with a nonmalaria febrile illness
3. attendance at a study health centre with malaria,
4. the prevalence of moderate anaemia at the end of each malaria transmission season,
5. nutritional status at the end of each malaria transmission season,
6. prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season,
7. prevalence of resistance markers to SP at the end of the study,

Sample size: 19,200 children (9600 in each country) will be enrolled.

Conditions

Interventions

DRUG

Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin

Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season

DRUG

Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin

Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season

Sponsors & Collaborators

  • Malaria Research and Training Center, Bamako, Mali

    collaborator OTHER

  • Institut de Recherche en Sciences de la Sante, Burkina Faso

    collaborator OTHER_GOV

  • London School of Hygiene and Tropical Medicine

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-05-31
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Burkina Faso
  • Mali

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02211729 on ClinicalTrials.gov