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

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ClinicalTrials.gov Identifier: NCT02211729
Recruitment Status : Completed
First Posted : August 7, 2014
Last Update Posted : March 7, 2018
Sponsor:
Collaborators:
Malaria Research and Training Center, Bamako, Mali
Institut de Recherche en Sciences de la Sante, Burkina Faso
Information provided by (Responsible Party):
London School of Hygiene and Tropical Medicine

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. 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.


Condition or disease Intervention/treatment Phase
Malaria Respiratory Infections Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22090 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children
Actual Study Start Date : May 2014
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Seasonal malaria chemoprevention
Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin
Drug: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin
Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season

Experimental: seasonal malaria chemoprevention plus AZ
Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season
Drug: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin
Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season




Primary Outcome Measures :
  1. severe morbidity and mortality [ Time Frame: 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) ]
    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 Outcome Measures :
  1. macrolide resistant pneumococci carriage [ Time Frame: before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3, ]

Other Outcome Measures:
  1. out patient attendance for non malaria febrile illness [ Time Frame: from enrolment until the end of malaria transmission season in year 3 ]
    (b) attendance at a study health centre with a febrile illness that is not due to malaria (including acute respiratory infections and diarrhoea),

  2. OPD attendance for malaria [ Time Frame: from enrollment until the end of malaria transmission season in year 3 ]
    (c) attendance at a study health centre with RDT or microscopically proven malaria,

  3. moderate anaemia [ Time Frame: at the end of each malaria transmission season in year 1, 2, and 3 ]
    (d) the prevalence of moderate anaemia (Hb <8 g/dL) at the end of each malaria transmission season,

  4. nutritional status [ Time Frame: at the end of malaria transmission season in year 1, 2 and 3 ]
    (e) nutritional status at the end of each malaria transmission season,

  5. nasopharyngeal carriage [ Time Frame: before the administration of first dose of SMC and at the end of malaria transmission season in year 1, 2, and 3 ]
    (f) the prevalence of nasopharyngeal carriage with pneumococci before and at the end of each malaria transmissions season,

  6. SP resistance markers [ Time Frame: at the end of the malaria transmission season in year 3 ]
    (h) the prevalence of resistance markers to SP in children with Plasmodium falciparum malaria at the end of the study,

  7. adverse events [ Time Frame: 7 days after administration of SMC in rounds 1, 2, 3 and 4 in year one ]
    solicited adverse events 7 days after administration of SMC+AZ after each round in the year one of the study



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02211729


Locations
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Burkina Faso
Hounde district Hospital
Hounde, Burkina Faso
Mali
Bougouni Koulikoro District hospital
Bougouni, Mali
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
Malaria Research and Training Center, Bamako, Mali
Institut de Recherche en Sciences de la Sante, Burkina Faso

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT02211729     History of Changes
Other Study ID Numbers: MR/K007319/1
First Posted: August 7, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Respiratory Tract Infections
Malaria
Protozoan Infections
Parasitic Diseases
Infection
Respiratory Tract Diseases
Pyrimethamine
Sulfadoxine
Amodiaquine
Fanasil, pyrimethamine drug combination
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents