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| Name | Class |
|---|---|
| Malaria Research and Training Center, Bamako, Mali | OTHER |
| Institut de Recherche en Sciences de la Sante, Burkina Faso | OTHER_GOV |
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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:
Sample size: 19,200 children (9600 in each country) will be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seasonal malaria chemoprevention | Active Comparator | Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin |
|
| seasonal malaria chemoprevention plus AZ | Experimental | Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin | Drug | Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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, |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| OPD attendance for malaria |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hounde district Hospital | Houndé | Burkina Faso | ||||
| Bougouni Koulikoro District hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34644317 | Derived | 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. | |
| 32822362 |
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| Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin | Drug | Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season |
|
(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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Bougouni |
| Mali |
| Derived |
| 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. |
| 30699301 | Derived | 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. |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
| D000096724 | Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C001205 | fanasil, pyrimethamine drug combination |
| D000655 | Amodiaquine |
| ID | Term |
|---|---|
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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