NCT05979896

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 28, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 31, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2023

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2024

Completed
Last Updated

August 7, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

July 31, 2023

Last Update Submit

July 31, 2023

Conditions

Malaria

Keywords

Seasonal Malaria ChemopreventionChemoprevention efficacyAntimalarial drug resistance

Outcome Measures

Primary Outcomes (4)

  • 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).

    28 days

  • 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.

    28 days

  • 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.

    28 days

  • 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

    28 days preceding implementation of chemoprevention efficacy study component

Study Arms (1)

Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)

EXPERIMENTAL

Children aged 3-59 months will receive directly observed therapy of standard aged based dosing of Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) over 3 days.

Drug: Standard age based SPAQ administration for SMC

Interventions

Standard age based SPAQ administration for SMCDRUG

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.

Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)

Eligibility Criteria

Age3 Months - 59 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kwara Sentinell Site

Kwara, Nigeria

RECRUITING

MeSH Terms

Conditions

Malaria

Interventions

Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Professional Staff CommitteesQuality Assurance, Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Craig Bonnington

    Malaria Consortium

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Craig Bonnington

CONTACT

+447597549279C.BONNINGTON@MALARIACONSORTIUM.ORG

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: Cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 7, 2023

Study Start

July 28, 2023

Primary Completion

September 15, 2023

Study Completion

May 15, 2024

Last Updated

August 7, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

NG(1)