MalariaPhase 4NCT05979896
Chemoprevention Efficacy Study Nigeria
A Phase 4 study testing Standard age based SPAQ administration for SMC in people with Malaria, run by Malaria Consortium at 1 site in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 59 monthsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Standard age based SPAQ administration for SMC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteNigeria
- Study dates
- 28 Jul 2023to 15 May 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 59 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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)
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- Chronic illness of any kind.
- Treatment with an ACT in previous 2 weeks.
- Previous treatment with SPAQ this malaria season.
Trial locations and contacts
1 site in 1 country.
Nigeria1 site, 1 recruiting
- Recruiting
Kwara Sentinell Site
Kwara
Mohammed Abdulkadir
+2348065754333, docmohng@gmail.com
About this study
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.
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.
Read the 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.
- Conditions
- Malaria
- Being tested
- Standard age based SPAQ administration for SMC
- Keywords
- Seasonal Malaria Chemoprevention, Chemoprevention efficacy, Antimalarial drug resistance
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Standard age based SPAQ administration for SMC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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
Measured: 28 days preceding implementation of chemoprevention efficacy study component
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start28 Jul 2023
- Primary completion15 Sep 2023 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Cohort
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Malaria Consortium
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Craig Bonnington, Principal investigator, Malaria Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05979896
- Sponsor's protocol ID
- SMCNGPHASE1
- Status last verified
- Jul 2023
- First submitted
- 31 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05979896
- Acronym / sponsor ID
- SMCNGPHASE1
- Conditions
- Malaria
- Keywords
- Seasonal Malaria Chemoprevention, Chemoprevention efficacy, Antimalarial drug resistance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Malaria ConsortiumUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 15 Sep 2023 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Cohort
| Arm | Type | Receives |
|---|---|---|
| Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) | Experimental | Drug: Standard age based SPAQ administration for SMCChildren aged 3-59 months will receive directly observed therapy of standard aged based dosing of Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) over 3 days. |
Who may qualify
- Ages
- 3 to 59 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard age based SPAQ administration for SMCSulfadoxine-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. | Drug | Sulfadoxine-Pyrimethamine + Amodiaquine (SPAQ) |
Primary outcome
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites
Time frame: 28 days
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)
Time frame: 28 days
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)
Time frame: 28 days
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
Time frame: 28 days preceding implementation of chemoprevention efficacy study component
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Craig Bonnington principal investigator
Malaria Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Standard age based SPAQ administration for SMC in people with Malaria, run by Malaria Consortium at 1 site in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Craig Bonnington (+447597549279, C.BONNINGTON@MALARIACONSORTIUM.ORG), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chemoprevention failure as defined by qPCR positive parasites or malaria slide positive parasites (time frame: 28 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.