NCT02211729

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,090

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started May 2014

Typical duration for phase_3

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 7, 2014

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

3.7 years

First QC Date

July 17, 2014

Last Update Submit

March 6, 2018

Conditions

MalariaRespiratory Infections

Outcome Measures

Primary Outcomes (1)

  • severe morbidity and mortality

    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.

    from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)

Secondary Outcomes (1)

  • macrolide resistant pneumococci carriage

    before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3,

Other Outcomes (7)

  • out patient attendance for non malaria febrile illness

    from enrolment until the end of malaria transmission season in year 3

  • OPD attendance for malaria

    from enrollment until the end of malaria transmission season in year 3

  • moderate anaemia

    at the end of each malaria transmission season in year 1, 2, and 3

  • +4 more other outcomes

Study Arms (2)

Seasonal malaria chemoprevention

ACTIVE COMPARATOR

Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin

Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin

seasonal malaria chemoprevention plus AZ

EXPERIMENTAL

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

Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin

Interventions

Sulphadoxine-Pyrimethamine+ Amodiaquine+ AzithromycinDRUG

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

seasonal malaria chemoprevention plus AZ
Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycinDRUG

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

Seasonal malaria chemoprevention

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children of either sex aged 3-59 months of age at the start of each period of drug administration
  • parental consent is obtained.

You may not qualify if:

  • a severe, chronic illness,
  • a known allergy to one of the study drugs.
  • HIV+ children on cotrimoxazole prophylaxis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hounde district Hospital

Houndé, Burkina Faso

Location

Bougouni Koulikoro District hospital

Bougouni, Mali

Location

Related Publications (3)

  • Hema-Ouangraoua S, Tranchot-Diallo J, Zongo I, Kabore NF, Nikiema F, Yerbanga RS, Tinto H, Chandramohan D, Ouedraogo GA, Greenwood B, Ouedraogo JB. Impact of mass administration of azithromycin as a preventive treatment on the prevalence and resistance of nasopharyngeal carriage of Staphylococcus aureus. PLoS One. 2021 Oct 13;16(10):e0257190. doi: 10.1371/journal.pone.0257190. eCollection 2021.

    PMID: 34644317DERIVED

  • Cairns ME, Sagara I, Zongo I, Kuepfer I, Thera I, Nikiema F, Diarra M, Yerbanga SR, Barry A, Tapily A, Coumare S, Milligan P, Tinto H, Ouedraogo JB, Chandramohan D, Greenwood B, Djimde A, Dicko A. Evaluation of seasonal malaria chemoprevention in two areas of intense seasonal malaria transmission: Secondary analysis of a household-randomised, placebo-controlled trial in Hounde District, Burkina Faso and Bougouni District, Mali. PLoS Med. 2020 Aug 21;17(8):e1003214. doi: 10.1371/journal.pmed.1003214. eCollection 2020 Aug.

    PMID: 32822362DERIVED

  • Chandramohan D, Dicko A, Zongo I, Sagara I, Cairns M, Kuepfer I, Diarra M, Barry A, Tapily A, Nikiema F, Yerbanga S, Coumare S, Thera I, Traore A, Milligan P, Tinto H, Doumbo O, Ouedraogo JB, Greenwood B. Effect of Adding Azithromycin to Seasonal Malaria Chemoprevention. N Engl J Med. 2019 Jun 6;380(23):2197-2206. doi: 10.1056/NEJMoa1811400. Epub 2019 Jan 30.

    PMID: 30699301DERIVED

MeSH Terms

Conditions

MalariaRespiratory Tract Infections

Interventions

fanasil, pyrimethamine drug combinationAmodiaquine

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

August 7, 2014

Study Start

May 1, 2014

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations

MA(1)BU(1)