MalariaPhase 2/3NCT00146718
Anti-Malarial Drug Resistance in Cameroon
A Phase 2/3 study testing Amodiaquine and Sulphadoxine/Pyrimethamine in people with Malaria, run by London School of Hygiene and Tropical Medicine.
Trial summary
The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- Conditions the study is for
- Malaria
- What is being tested?
- Amodiaquine and Sulphadoxine/Pyrimethamine
- How many people
- 755 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to May 2005
- Phase
- Phase 2/3
- 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 6 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6-59 months of age
- Recorded temperature between 37.5oC and 39.5 oC
- Signs/symptoms of acute uncomplicated P. falciparum malaria.
- Positive microscopy for mono-infection with P falciparum malaria
- Asexual blood stage parasitaemia in the range 1,000 to 100,000 asexual parasites per ul
- Consent from parent or guardian of a child.
- No other apparent cause for the child's illness.
Who cannot join
- Presence of signs of severe complicated falciparum malaria.
- Cerebral malaria (unrousable coma)
- Vomiting > twice within preceding 24 hours
- More than one convulsion within preceding 24 hours
- Inability to drink or breast-feed, or to take oral medication
- Haemoglobin less than 5g/dl or a hematocrit of less than 15%.
Show all 11Show fewer
- Documented evidence of adequate treatment with drugs expected to be effective in the preceding 72 hours
- Presence of underlying diseases (cardiac, renal, hepatic,malnutrition, gastrointestinal)
- History of allergy to study drug
- Inability to attend for the stipulated follow-up visits,
- Difficulty in accessing the health facility, or any situation or condition which may compromise the patients ability to comply with the trial procedures.
About this study
Official title: Anti-malarial Drug Resistance in Cameroon: Therapeutic Efficacy and Biological Markers of Resistance
The project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
Read the detailed description
The objectives of this study are:- .
- to evaluate the therapeutic efficacy of amodiaquine(AQ), Fansidar(SP) and the combination amodiaquine/Fansidar in three sites in Cameroon namely, Garoua (Sahel-savanna), Yaounde (Forest-savannah mosaic) and Limbe (Littoral-forest)
- to determine the prevalence of molecular markers associated with resistance to chloroquine,AQ,and SP in Limbe and Garoua and of mefloquine in Yaounde.
- to investigate biological factors that may enhance anti-malaria therapeutic efficacy. This will involve an exploratory, pilot study conducted during the second year of the program.
Patients will be rapidly screened for temperature and sent to the laboratory to determine the presence or absence of malaria parasites. The patients will then be examined clinically for inclusion or exclusion. Consent will be sort from the parents and the children randomised and assigned study numbers. To avoid bias in assigning the patients to groups and to ensure equal numbers in the treatment groups, blocked randomization will be performed, using a table of random variables of varying block sizes. The physician is blinded to what treatment the patient gets.
Amodiaquine will be administered at 10mg/kg on each of the three days to children in the AQ treatment group, together with Fansidar dummy tablets. Fansidar will be given at 25 mg/kg on day 0 and quinine as rescue drug at 10mg/kg per 8H for 6 days. For the AQ/SP combination, on D0, patients will be given both 25 mg/kg SP and 10mg/kg AQ. On subsequent days the AQ or its dummy tablets(SP arm) will be given.
Clinical assessment during the study will include: physical examination and monitoring of vital signs on D0, D3, D7, D14 and D28. Hematological measurements will include: blood films, haemoglobin,glucose,blood drug levels,and baseline haematology. A maximum of 3ml of blood will be withdrawn from the patients in Yaoundé for complete analyses(see below). For patients recruited at Limbe and Garoua only finger prick blood filter paper samples will be obtained.
Day 0 blood samples (3mL) will be collected aseptically by venepuncture before therapy from each of 50 patients in Yaoundé using acid-citrate-dextrose buffer (ACD) as anticoagulant. This will be processed to provide plasma for immunological determinations and for haematology and blood drug level determinations.
The molecular characterization of diversity and mutations:
- the genetic heterogeneity of the study population will be established using primers for msp1 and msp2 shown previously to distinguish between strains.
- PCR products will be digested with restriction enzyme (RFLP-PCR) for pyrimethamine resistance genes dhfr and dhps, and for chloroquine resistant strains of the pfcrtgene.
- Conditions
- Malaria
- Being tested
- Amodiaquine and Sulphadoxine/Pyrimethamine
- Keywords
- malaria, drug resistance, antimalarials
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amodiaquine and Sulphadoxine/PyrimethamineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequate clinical and parasitological response(ACPR) on Day 28
Secondary outcomes (3)
ACPR Day 14
Early treatment failure, between days 1 and 3
Late treatment failure, between days 4 and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startAug 2003
- Study completionMay 2005
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 755 participants
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Yaounde
- Responsible party
- Principal investigator, Brian Greenwood, London School of Hygiene and Tropical Medicine
- Investigators
- Wilfred Mbacham, ScD, Principal investigator, Laboratory for Public Health Biotechnology, University of Yaounde I
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146718
- Sponsor's protocol ID
- ITDCVG34
- Status last verified
- Jan 2017
- First submitted
- 5 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-malarial Drug Resistance in Cameroon: Therapeutic Efficacy and Biological Markers of Resistance
- ClinicalTrials.gov ID
- NCT00146718
- Acronym / sponsor ID
- ITDCVG34
- Conditions
- Malaria
- Keywords
- malaria, drug resistance, antimalarials
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 755 participants
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Yaounde
- Study start
- Aug 2003
- Study completion
- May 2005
- First posted
- 7 Sep 2005 (estimated)
- 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 project is a three-armed study designed to evaluate the efficacy of amodiaquine(AQ), sulphadoxine-pyrimethamine(SP) and(AQ+SP) in three sites in Cameroon that differ in their baseline characteristics for malaria. In addition, drug resistance will be determined by measurement of blood drug levels,and identification of molecular markers of resistance.
Detailed description
The objectives of this study are:- .
- to evaluate the therapeutic efficacy of amodiaquine(AQ), Fansidar(SP) and the combination amodiaquine/Fansidar in three sites in Cameroon namely, Garoua (Sahel-savanna), Yaounde (Forest-savannah mosaic) and Limbe (Littoral-forest)
- to determine the prevalence of molecular markers associated with resistance to chloroquine,AQ,and SP in Limbe and Garoua and of mefloquine in Yaounde.
- to investigate biological factors that may enhance anti-malaria therapeutic efficacy. This will involve an exploratory, pilot study conducted during the second year of the program.
Patients will be rapidly screened for temperature and sent to the laboratory to determine the presence or absence of malaria parasites. The patients will then be examined clinically for inclusion or exclusion. Consent will be sort from the parents and the children randomised and assigned study numbers. To avoid bias in assigning the patients to groups and to ensure equal numbers in the treatment groups, blocked randomization will be performed, using a table of random variables of varying block sizes. The physician is blinded to what treatment the patient gets.
Amodiaquine will be administered at 10mg/kg on each of the three days to children in the AQ treatment group, together with Fansidar dummy tablets. Fansidar will be given at 25 mg/kg on day 0 and quinine as rescue drug at 10mg/kg per 8H for 6 days. For the AQ/SP combination, on D0, patients will be given both 25 mg/kg SP and 10mg/kg AQ. On subsequent days the AQ or its dummy tablets(SP arm) will be given.
Clinical assessment during the study will include: physical examination and monitoring of vital signs on D0, D3, D7, D14 and D28. Hematological measurements will include: blood films, haemoglobin,glucose,blood drug levels,and baseline haematology. A maximum of 3ml of blood will be withdrawn from the patients in Yaoundé for complete analyses(see below). For patients recruited at Limbe and Garoua only finger prick blood filter paper samples will be obtained.
Day 0 blood samples (3mL) will be collected aseptically by venepuncture before therapy from each of 50 patients in Yaoundé using acid-citrate-dextrose buffer (ACD) as anticoagulant. This will be processed to provide plasma for immunological determinations and for haematology and blood drug level determinations.
The molecular characterization of diversity and mutations:
- the genetic heterogeneity of the study population will be established using primers for msp1 and msp2 shown previously to distinguish between strains.
- PCR products will be digested with restriction enzyme (RFLP-PCR) for pyrimethamine resistance genes dhfr and dhps, and for chloroquine resistant strains of the pfcrtgene.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children 6-59 months of age
- Recorded temperature between 37.5oC and 39.5 oC
- Signs/symptoms of acute uncomplicated P. falciparum malaria.
- Positive microscopy for mono-infection with P falciparum malaria
- Asexual blood stage parasitaemia in the range 1,000 to 100,000 asexual parasites per ul
Key exclusion criteria (11 listed)
- Presence of signs of severe complicated falciparum malaria.
- Cerebral malaria (unrousable coma)
- Vomiting > twice within preceding 24 hours
- More than one convulsion within preceding 24 hours
- Inability to drink or breast-feed, or to take oral medication
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 |
|---|---|---|
| Amodiaquine and Sulphadoxine/Pyrimethamine | Drug | – |
Primary outcome
Adequate clinical and parasitological response(ACPR) on Day 28
3 secondary outcomes
ACPR Day 14
Early treatment failure, between days 1 and 3
Late treatment failure, between days 4 and 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
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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.
Wilfred Mbacham, ScD principal investigator
Laboratory for Public Health Biotechnology, University of Yaounde I
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Amodiaquine and Sulphadoxine/Pyrimethamine in people with Malaria, run by London School of Hygiene and Tropical Medicine.
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 7 inclusion and 11 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: finished, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequate clinical and parasitological response(ACPR) on Day 28. 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 12 Jan 2017.