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Seasonal Malaria Chemoprevention With Dihydroartemisin Piperaquin vs. Sulfadoxine-pyrimethamin+Amodiaquin

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ClinicalTrials.gov Identifier: NCT04149106
Recruitment Status : Recruiting
First Posted : November 4, 2019
Last Update Posted : November 5, 2019
Sponsor:
Collaborators:
Tulane University
University of South Florida
University of Copenhagen
Deakin University
Johns Hopkins University
Information provided by (Responsible Party):
University Clinical Research Center, Mali

Brief Summary:

Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four (4) rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria.

The proposed study will examine the effect of SMC with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC. The specific aims of this study are to: 1] Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites; 2] Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years; 3] Determine the cost-effectiveness for each treatment regimen; ) 4] Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and 5) Establish a district based system to identify severe cases.

The expected outcomes of this work, upon completion of our specific aims, include 1) Recommendations to Malian health officials and other partners for improving implementation of SMC and alternative drug to SP+AQ for SMC, and 2) Guidelines for routine monitoring of SMC implementation.


Condition or disease Intervention/treatment Phase
Malaria,Falciparum Drug: Sulfadoxine pyrimethamine + Amodiaquin Drug: Dihydroartemisinin piperaquin Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4556 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

A cluster randomized design will be used.

Year 1:

Arm 1: Standard of care defined as SPAQ for children less than 5 years old according the NMCP national politic for malaria control Arm2: SPAQ will be delivery to children 3 months to less than 10 years (extension of SMC to children 5-9 years with current drug) Arm 3: DHAPQ will be delivery to children 3 months to less than 10 years

Year 2:

Arm 1: SPAQ will be delivery to children 3 months to less than 10 years (extension of SMC to children 5-9 years with current drug) Arm2: DHAPQ will be delivery to children 3 months to less than 10 years Arm 3: Standard of care defined as SPAQ for children less than 5 years old according the NMCP national politic for malaria control

Masking: None (Open Label)
Masking Description: Any
Primary Purpose: Prevention
Official Title: Effectiveness of Seasonal Malaria Chemoprevention in Koulikoro, Mali
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : October 30, 2020
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

Arm Intervention/treatment
Active Comparator: Standard
The Mali National Malaria Control program has initiated SMC for children less than 5 years since 2016 (countrywide) with SPAQ. This standard care will not change in this arm
Drug: Sulfadoxine pyrimethamine + Amodiaquin
Monthly dose of SPAQ over three days for SMC
Other Name: SPAQ

Active Comparator: SMC with SPAQ extended to older children
Within this arm, SMC with SPAQ will be extended to children 5-9 years old
Drug: Sulfadoxine pyrimethamine + Amodiaquin
Monthly dose of SPAQ over three days for SMC
Other Name: SPAQ

Active Comparator: SMC with DHAPQ
Children less than 10 years within this arm will received Dihydroartemisin piperaquin for SMC instead of SPAQ
Drug: Dihydroartemisinin piperaquin
Monthly dose of DHAPQ for SMC
Other Name: DHAPQ




Primary Outcome Measures :
  1. Malaria incidence among cohort in 2 years period [ Time Frame: 2 years ]
    The incidence of malaria (uncomplicated or severe malaria): Uncomplicated malaria being defined as symptomatic malaria parasitaemia with no signs of severity and/or evidence of vital organ dysfunction measured by: (1) rapid diagnostic tests and/or (2) microscopy of blood smears. Severe malaria is defined as confirmed malaria parasitemia plus fever or history of fever (at least 37°C) plus evidence of severe/complicated pathology; e.g., convulsions, vomiting, coma, rapid (kussumal) breathing or evidence of vital organ dysfunction, and severe anemia.


Secondary Outcome Measures :
  1. Malaria infection prevalence at the start and the end of malaria transmission season [ Time Frame: 2 years ]
    include changes in the prevalence of P. falciparum parasitemia and anemia measured during cross-sectional surveys before SMC provision (June/July the beginning of transmission season) and after fourth round provision of SMC

  2. Drug resistance marker prevalence in two 2 years period [ Time Frame: 1 year ]
    prevalence of immunological markers for P. falciparum malaria, prevalence of molecular markers of drug resistance

  3. SMC coverage and treatment compliance during malaria transmission season [ Time Frame: 2 years ]
    total number of age eligible children sampled reporting to have received SMC and number of children who received SMC with drug metabolites in their blood divided by number of age eligible children in sample.


Other Outcome Measures:
  1. Malaria control tools usage in communities [ Time Frame: 2 years ]
    Estimates of the coverage and usage rates for malaria control tools (bed nets, antimalarial drugs



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   3 Months to 119 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Village resident (up to the end of the malaria transmission season)
  • Age 3 months to 119 month age at the time of enrollment
  • Parent or guardian provided consent for their child's participant (5-14 years old)
  • Absence of chronic diseases, history of allergy to SP, AQ or DHA-PQ

Exclusion Criteria:

Non resident

  • Age less than 3months or greater or equal to 119 months at the time of cohort enrollment
  • Presence of chronic diseases, history of allergy to SP, AQ or DHA-PQ
  • Does not provide consent/assent required according to age to participate in the study

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): NCT04149106


Contacts
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Contact: Seydou Doumbia, PhD +223 76461339 sdoumbi@gmail.org
Contact: Mahamoudou Toure, MD-MsPH +22366778912 mah.toure@gmail.com

Locations
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Mali
Ucrc - Usttb Recruiting
Bamako, Select, Mali, B.P. 5445
Contact: Seydou Doumbia, PhD    +223 76461339    sdoumbi@icermali.org   
Contact: Mahamoudou Toure, MD-MsPH    +22366778912    mah.toure@gmail.com   
Sponsors and Collaborators
University Clinical Research Center, Mali
Tulane University
University of South Florida
University of Copenhagen
Deakin University
Johns Hopkins University
Investigators
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Study Director: Seydou Doumbia, PhD University Clinical Research Center - USTTB - Mali
Additional Information:
Publications:
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Responsible Party: University Clinical Research Center, Mali
ClinicalTrials.gov Identifier: NCT04149106    
Other Study ID Numbers: 17-0052
First Posted: November 4, 2019    Key Record Dates
Last Update Posted: November 5, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: genomic data will be shared with Deakin University. Sharing data and resources arising from the genomics research will be a key activity of the research team. In order to prevent unnecessary duplication and to encourage collaboration, we will make the data and resources available to the malaria research community using several different means. Data arising from the research activities will be submitted to appropriate data repositories. This will include DRYAD for sample genotyping data and the GenBank for all NGS raw data. Other types of data e.g. results of sequence analyses will be published in the scientific literature. We will liaise with EuPathDB to integrate genetic, infection, and associated meta-data into EuPathDB databases. EuPathDB houses the NIH-funded Plasmodium database resource, PlasmoDB. Protocols describing new assays and laboratory methods will be published in the scientific literature. We will publish results in order to increase awareness of the scientific world.
Supporting Materials: Analytic Code
Time Frame: All data and resources will be made available as soon as possible but no later than within one year of the completion of the funded project period (2021) or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.
Access Criteria: we will identify where the data will be available and how to access the data in any publications and presentations that we author or co-author about these data, as well as acknowledge the repository and funding source in any publications and presentations. All repositories mentioned have policies and procedures in place that will provide data access to qualified researchers or registered users, fully consistent with NIH data sharing policies and applicable laws and regulations.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University Clinical Research Center, Mali:
SMC
Effectiveness
SPAQ
DHAPQ
Drug resistance
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Pyrimethamine
Sulfadoxine
Fanasil, pyrimethamine drug combination
Amodiaquine
Dihydroartemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Folic Acid Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents, Urinary
Renal Agents