A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

Malaria Clinical Trial

— SMCAZ  

Official title:

A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02211729
• Other study ID #: MR/K007319/1
• Status: Completed
• Phase: Phase 3
• First received: July 17, 2014
• Last updated: March 6, 2018
• Start date: May 2014
• Est. completion date: December 31, 2017

Study information

• Verified date: March 2018
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22090
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Months to 59 Months

Eligibility

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

Related Conditions & MeSH terms

• Malaria
• Respiratory Infections
• Respiratory Tract Infections

Intervention

Drug:
• Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin
Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season
• Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin
Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season

Locations

Country	Name	City	State
Burkina Faso	Hounde district Hospital	Hounde
Mali	Bougouni Koulikoro District hospital	Bougouni

Sponsors (3)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Institut de Recherche en Sciences de la Sante, Burkina Faso, Malaria Research and Training Center, Bamako, Mali

Countries where clinical trial is conducted

Burkina Faso,  Mali, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	out patient attendance for non malaria febrile illness	(b) attendance at a study health centre with a febrile illness that is not due to malaria (including acute respiratory infections and diarrhoea),	from enrolment until the end of malaria transmission season in year 3
Other	OPD attendance for malaria	(c) attendance at a study health centre with RDT or microscopically proven malaria,	from enrollment until the end of malaria transmission season in year 3
Other	moderate anaemia	(d) the prevalence of moderate anaemia (Hb <8 g/dL) at the end of each malaria transmission season,	at the end of each malaria transmission season in year 1, 2, and 3
Other	nutritional status	(e) nutritional status at the end of each malaria transmission season,	at the end of malaria transmission season in year 1, 2 and 3
Other	nasopharyngeal carriage	(f) the prevalence of nasopharyngeal carriage with pneumococci before and at the end of each malaria transmissions season,	before the administration of first dose of SMC and at the end of malaria transmission season in year 1, 2, and 3
Other	SP resistance markers	(h) the prevalence of resistance markers to SP in children with Plasmodium falciparum malaria at the end of the study,	at the end of the malaria transmission season in year 3
Other	adverse events	solicited adverse events 7 days after administration of SMC+AZ after each round in the year one of the study	7 days after administration of SMC in rounds 1, 2, 3 and 4 in year one
Primary	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	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,