Back to resultsChemoprevention Efficacy Study Nigeria
Primary Purpose
Malaria
Status
Recruiting
Phase
Phase 4
Locations
Nigeria
Study Type
Interventional
Intervention
Standard age based SPAQ administration for SMC
Sponsored by
About this trial
This is an interventional prevention trial for Malaria focused on measuring Seasonal Malaria Chemoprevention, Chemoprevention efficacy, Antimalarial drug resistance
Eligibility Criteria
Inclusion criteria Children between 3-59 months. Being resident in the research study area. Afebrile children with no other malaria associated symptoms in the past 48 hours or at time of recruitment. Consent to participate in the study obtained. Can comply with 3 days DOT of standard SPAQ regimen. Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections. Exclusion criteria Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours) Known allergy to SPAQ. Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole). Individuals receiving azithromycin due to the antimalarial activity of azithromycin. Severe malnutrition according to WHO guidelines HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz) Chronic illness of any kind. Treatment with an ACT in previous 2 weeks. Previous treatment with SPAQ this malaria season.
Sites / Locations
- Kwara Sentinell SiteRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Arm Description
Children aged 3-59 months will receive directly observed therapy of standard aged based dosing of Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) over 3 days.
Outcomes
Primary Outcome Measures
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
Malaria slides and dry blood spots (DBS) taken at days 0,7,14, 21, 28 of a one month drug administration cycle will be analysed to detect parasitemia in children treated with SPAQ. Chemoprevention failure has occured if a malaria slide is positive for parasites 7 days or more after drug administration or if a qPCR detects low level parasitemia at the end of the administration cycle (one month).
Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
All Dried blood spots (DBS) will be analysed for malaria mutation genotypes (dhfr, dhps, Pfcrt, pfmdr1) on baseline and endline and additionally throughout the cycle if a chemoprevention failure (as defined in outcome 1) has occured.
Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
Drug concentrations of SPAQ will be analyzed on all samples (taken at days 7,14,21,28 throughout the one month cycle) in order to be linked to chemoprevention failures as defined in outcome 1.
Prevalence over time of parasites with dhfr/dhps/pfcrt/pfmdr1 mutations in symptomatic children with a positive diagnostic test residing in districts where SMC is implemented
The outcome measure to meet the secondary objective is the prevalence of molecular markers associated with SP (codons 108, 51 and 59 in dhfr and 437, 540 and 581 in dhps) and amodiaquine (codons 72-76 Pfcrt and 86, 184 and 1246 pfmdr1), as well as other markers of parasite genetic diversity, in blood samples collected from symptomatic children under five years with a positive RDT attending selected health facilities in areas with SMC
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05979896
Brief Title
Chemoprevention Efficacy Study Nigeria
Official Title
A Study Protocol to Assess the Chemoprevention Efficacy of Sulphadoxine-Pyrimethamine Plus Amodiaquine (SPAQ) and Resistance Marker Prevalence in Children 3-59 Months in Sokoto and Kwara States, Nigeria.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Malaria Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to assess the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens used in Seasonal Malaria Chemoprevention (SMC) and SPAQ resistance marker prevalences and assocations among children 3 - 59 months in Sokoto and Kwara States, Nigeria.
Detailed Description
The study aims (1) to determine the chemoprevention efficacy of Sulfadoxine-Pyrimethamine and Amodiaquine (SPAQ) used in standard age-based dosing regimens for Seasonal Malaria Chemoprevention (SMC) in children 3-59 months and (2) determine the prevalences and associations of drug resistance genotypes associated with resistance to SPAQ.
a prospective cohort study to determine the chemoprevention efficacy of SPAQ (if SPAQ provides 28 days of protection from Plasmodium falciparum (P. falciparum) malaria infection by clearing existing and preventing new infections) and whether drug concentrations and/or resistance influence the ability to clear and prevent these P. falciparum infections.
a resistance markers study in symptomatic RDT positive children 3-59 months to measure sulfadoxine-pyrimethamine and amodiaquine resistance marker prevalence and association.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Seasonal Malaria Chemoprevention, Chemoprevention efficacy, Antimalarial drug resistance
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
Cohort
Masking
None (Open Label)
Allocation
N/A
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)
Arm Type
Experimental
Arm Description
Children aged 3-59 months will receive directly observed therapy of standard aged based dosing of Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) over 3 days.
Intervention Type
Drug
Intervention Name(s)
Standard age based SPAQ administration for SMC
Intervention Description
Sulfadoxine-pyrimethamine and amodiaquine (SPAQ) is administered in standard WHO approved age based regimens as used in Seasonal Malaria Chemoprevention Programmes.
Sulphadoxine is a slowly eliminated sulphonamide. It is used in a fixed dose combination of 20 parts sulphadoxine with 1 part pyrimethamine given orally or intramuscularly.
Sulphadoxine is readily absorbed from the GIT. It is widely distributed in body tissues and fluids and crosses the placenta into foetal circulation. It is also readily detectable in breast milk. It is excreted predominantly as the unchanged drug. AQ Amodiaquine is a Mannich base 4 amino-quinoline that interferes with parasite haem detoxification. It is more effective than chloroquine in both chloroquine sensitive and resistant P. falciparum infections. However, there is cross-resistance between chloroquine and amodiaquine.
It is readily absorbed in the GIT and rapidly converted in the liver to the active metabolite, desethylamodiaquine.
Primary Outcome Measure Information:
Title
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
Description
Malaria slides and dry blood spots (DBS) taken at days 0,7,14, 21, 28 of a one month drug administration cycle will be analysed to detect parasitemia in children treated with SPAQ. Chemoprevention failure has occured if a malaria slide is positive for parasites 7 days or more after drug administration or if a qPCR detects low level parasitemia at the end of the administration cycle (one month).
Time Frame
28 days
Title
Prevalence of antimalarial resistance markers among chemoprevention failures (as defined in outcome 1)
Description
All Dried blood spots (DBS) will be analysed for malaria mutation genotypes (dhfr, dhps, Pfcrt, pfmdr1) on baseline and endline and additionally throughout the cycle if a chemoprevention failure (as defined in outcome 1) has occured.
Time Frame
28 days
Title
Drug concentrations of Sulfadoxine-pyrimethamine and amodiaquine among chemoprevention failures (as defined in outcome 1)
Description
Drug concentrations of SPAQ will be analyzed on all samples (taken at days 7,14,21,28 throughout the one month cycle) in order to be linked to chemoprevention failures as defined in outcome 1.
Time Frame
28 days
Title
Prevalence over time of parasites with dhfr/dhps/pfcrt/pfmdr1 mutations in symptomatic children with a positive diagnostic test residing in districts where SMC is implemented
Description
The outcome measure to meet the secondary objective is the prevalence of molecular markers associated with SP (codons 108, 51 and 59 in dhfr and 437, 540 and 581 in dhps) and amodiaquine (codons 72-76 Pfcrt and 86, 184 and 1246 pfmdr1), as well as other markers of parasite genetic diversity, in blood samples collected from symptomatic children under five years with a positive RDT attending selected health facilities in areas with SMC
Time Frame
28 days preceding implementation of chemoprevention efficacy study component
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
59 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria
Children between 3-59 months.
Being resident in the research study area.
Afebrile children with no other malaria associated symptoms in the past 48 hours or at time of recruitment.
Consent to participate in the study obtained.
Can comply with 3 days DOT of standard SPAQ regimen.
Willingness and ability of the child's guardians to comply with the study protocol for the duration of the study including all dry blood spot and slide collections.
Exclusion criteria
Symptoms of malaria (tympanic fever ≥ 37.5 °C or history of fever in past 48 hours)
Known allergy to SPAQ.
Receiving a sulfa-based medication for treatment or prophylaxis, including co-trimoxazole (trimethoprim-sulfamethoxazole).
Individuals receiving azithromycin due to the antimalarial activity of azithromycin.
Severe malnutrition according to WHO guidelines
HIV positive or ARV use (SPAQ MUST NEVER be used with children taking the antiretroviral efavirenz)
Chronic illness of any kind.
Treatment with an ACT in previous 2 weeks.
Previous treatment with SPAQ this malaria season.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Craig Bonnington
Phone
+447597549279
Email
C.BONNINGTON@MALARIACONSORTIUM.ORG
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Craig Bonnington
Organizational Affiliation
Malaria Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kwara Sentinell Site
City
Kwara
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mohammed Abdulkadir
Phone
+2348065754333
Email
docmohng@gmail.com
First Name & Middle Initial & Last Name & Degree
Mohammed Abdulkadir, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
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