Chemoprevention Efficacy Study Nigeria

NCT ID: NCT05979896

Last Updated: 2023-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-28
• Study Completion Date: 2024-05-15

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.

1. 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.

2. a resistance markers study in symptomatic RDT positive children 3-59 months to measure sulfadoxine-pyrimethamine and amodiaquine resistance marker prevalence and association.

Conditions

Malaria

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ)

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

Group Type: EXPERIMENTAL

Standard age based SPAQ administration for SMC

Intervention Type: DRUG

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.

Interventions

Standard age based SPAQ administration for SMC

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 59 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Malaria Consortium

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Bonnington

Role: PRINCIPAL_INVESTIGATOR

Malaria Consortium

Locations

Kwara Sentinell Site

Kwara, , Nigeria

Site Status: RECRUITING

Countries

Nigeria

Central Contacts

Craig Bonnington

Role: CONTACT

C.BONNINGTON@MALARIACONSORTIUM.ORG

+447597549279

Facility Contacts

Mohammed Abdulkadir

Role: primary

Role: backup

docmohng@gmail.com

+2348065754333

Other Identifiers

SMCNGPHASE1

Identifier Type: -

Identifier Source: org_study_id