A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children (SMCAZ)

London School of Hygiene and Tropical Medicine

Status and phase: Completed; Phase 3

Conditions: Respiratory Infections; Malaria

Treatments: Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin; Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin

Study type: Interventional

Funder types: Other

Identifiers

NCT02211729

MR/K007319/1

Details and patient eligibility

About

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.

Enrollment: 22,090 patients

Sex: All

Ages: 3 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

22,090 participants in 2 patient groups

Seasonal malaria chemoprevention

Active Comparator group

Description:

Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin

Treatment:

Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin

seasonal malaria chemoprevention plus AZ

Experimental group

Description:

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

Treatment:

Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin