MalariaPhase 3NCT00297882
Artemisinin-Based Combination Therapy: Clinical Trials in Cameroon
A Phase 3 study testing 1. Artemether-Lumefantrine (AL) and 2. Amodiaquine-Artesunate (AQ-AS) in people with Malaria, run by London School of Hygiene and Tropical Medicine.
Trial summary
This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Read more about this study
- Who is it for?
- Ages 6 to 120 months
- Conditions the study is for
- Malaria
- What is being tested?
- 1. Artemether-Lumefantrine (AL) and 2. Amodiaquine-Artesunate (AQ-AS)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 816 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 120 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children aged 6-120 months;
- axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
- P. falciparum asexual parasitemia between 1000 and 100000/µl;
- ability to attend follow-up visits.
Who cannot join
- co-infections;
- underlying chronic disease;
- severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
- recent history of multiple convulsions;
- jaundice;
- the inability to stand or sit;
- history of allergy to study drugs.
About this study
Official title: Phase III Clinical Trials of Artemisinin-based Combination Therapy in Cameroon
This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs, and on putative marker mutations of the development of resistance to ACT. The study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be determined using a WHO standardized 28-day protocol. Safety will be monitored through clinical examination and biochemical and hematological indices. Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy.
Read the detailed description
- Outpatients will be screened for malaria by blood film examination
- Malaria-positive children will be examined by the physician for inclusion or exclusion(see below)
- Informed consent will be sought from the guardians of potential patients
- Patients or guardians will be interviewed and a case record form completed
- Patients will be randomized into one of the two arms in the ratio 4:1 AQ/Art: CoArtem and issued a study card
- Filter paper and 5ml venous blood samples will be collected
- Patients will be hospitalised for three days to allow completion of therapy under observation
- The patient will be asked to return on days 7, 14 and 28 for assessment of clearance or recrudescence of parasites
- Patient will be examined for parasites and evaluated for early treatment failure (ETF), late treatment failure (LTF), late parasitological failure (LPF) or adequate clinical and parasitological response.(ACPR).
- If a patient does not appear for follow up, a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature ≥ 37.5°C
- Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
- Filter paper samples will be air dried and stored with dessicant until required.
- Whole blood samples collected into citrate as anticoagulant will be processed for plasma, aliquoted into 300µl lots and stored at -70°C.
- Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week, along with the hard copies of the case report forms.
- Analysis will be performed on the samples within three months of collection for molecular markers of resistance, genetic structure of parasites and for blood drug levels of medications used in the trial
- Conditions
- Malaria
- Being tested
- 1. Artemether-Lumefantrine (AL), 2. Amodiaquine-Artesunate (AQ-AS)
- Keywords
- Efficacy, Safety, Children, Cameroon
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. Artemether-Lumefantrine (AL)Drug
Also called CoArtem
Artemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart).
2. Amodiaquine-Artesunate (AQ-AS)Drug
Also called Arsucam
Amodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg
| Study group | Role | What they receive |
|---|---|---|
| 1 Artemether-Lumefantrine (AL) | Active comparator | Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days. Receives: Drug: 1. Artemether-Lumefantrine (AL) |
| 2 Amodiaquine-Artesunate (AQ-AS) | Active comparator | Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days. Receives: Drug: 2. Amodiaquine-Artesunate (AQ-AS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rate on Day 28
To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua
Measured: Day 0 - 28
Secondary outcomes (1)
Cure Rate Day 14
To evaluate antimalarial efficacy of AL and AQ-AS on day 14 post-treatment
Measured: Day 0-14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2006 (estimated)
- Study startJul 2006
- Primary completionApr 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 816 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Yaounde, Cameroon Baptist Convention Health
- Responsible party
- Principal investigator, Brian Greenwood, London School of Hygiene and Tropical Medicine
- Investigators
- Wilfred F Mbacham, ScD, Principal investigator, University of Yaounde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00297882
- Sponsor's protocol ID
- ITCRVG46
- Status last verified
- May 2021
- First submitted
- 28 Feb 2006
- Last updated
- 8 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Database available on request of Prof Wilfred Mbacham wfmbacham@yahoo.com
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Clinical Trials of Artemisinin-based Combination Therapy in Cameroon
- ClinicalTrials.gov ID
- NCT00297882
- Acronym / sponsor ID
- ITCRVG46
- Conditions
- Malaria
- Keywords
- Efficacy, Safety, Children, Cameroon
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 816 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Yaounde, Cameroon Baptist Convention Health
- Study start
- Jul 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 1 Mar 2006 (estimated)
- Results
- Posted 8 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proposal aims to evaluate the safety and efficacy of artemisinin-based anti-malaria combination drugs (ACTs) for the treatment of children aged 6-120 months in different locations in Cameroon. Randomized clinical trials will provide local data on the safety of the test drugs, and on putative marker mutations of the development of resistance to ACT. The study will involve three centers, namely, Banso (Guinea-Savannah region), Limbe(Littoral Forest), and Garoua(Sahel-Savannah). The trial will compare the efficacy and safety of Amodiaquine(AQ)-Artesunate(Art) with Coartem®(Artemether-Lumefantrine). Drug efficacy will be determined using a WHO standardized 28-day protocol. Safety will be monitored through clinical examination and biochemical and hematological indices. Molecular markers of artemisinin resistance will be investigated by molecular sequencing and comparison of parasite profiles of the PfATP6 gene in drug failure cases, . Recrudescences or re-infections will be assessed by analysis of the msp1 and msp2 genes. The impact of these combinations on generation of gametocytes will be determined from gametocyte carriage rates measured by microscopy.
Detailed description
- Outpatients will be screened for malaria by blood film examination
- Malaria-positive children will be examined by the physician for inclusion or exclusion(see below)
- Informed consent will be sought from the guardians of potential patients
- Patients or guardians will be interviewed and a case record form completed
- Patients will be randomized into one of the two arms in the ratio 4:1 AQ/Art: CoArtem and issued a study card
- Filter paper and 5ml venous blood samples will be collected
- Patients will be hospitalised for three days to allow completion of therapy under observation
- The patient will be asked to return on days 7, 14 and 28 for assessment of clearance or recrudescence of parasites
- Patient will be examined for parasites and evaluated for early treatment failure (ETF), late treatment failure (LTF), late parasitological failure (LPF) or adequate clinical and parasitological response.(ACPR).
- If a patient does not appear for follow up, a community health worker will try to trace them and will collect blood onto filter paper and a microscope slide should the patient have a temperature ≥ 37.5°C
- Patients whose parents opt out of the study will be administered quinine sulphate if parasitaemic
- Filter paper samples will be air dried and stored with dessicant until required.
- Whole blood samples collected into citrate as anticoagulant will be processed for plasma, aliquoted into 300µl lots and stored at -70°C.
- Patient information will be entered at the close of each day into laptops and collectively sent to Yaounde at the end of the first month of study and thereafter at the end of each week, along with the hard copies of the case report forms.
- Analysis will be performed on the samples within three months of collection for molecular markers of resistance, genetic structure of parasites and for blood drug levels of medications used in the trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 Artemether-Lumefantrine (AL) | Active comparator | Drug: 1. Artemether-Lumefantrine (AL)Study group 1. Subjects in this group received treatment with Artemether-Lumefantrine. Children received 2 mg/kg Artemether and 12 mg/kg Lumefrantrine with milk twice daily (or every 12 hours for 3 days. |
| 2 Amodiaquine-Artesunate (AQ-AS) | Active comparator | Drug: 2. Amodiaquine-Artesunate (AQ-AS)Study group 2. Subjects in this group received treatment with Amodiaquine-Artesunate. Children received a co-administered combination of 30 mg/kg Amodiaquine (AQ) plus 4 mg/kg Artesunate (AS) daily for 3 days. |
Who may qualify
- Ages
- 6 to 120 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children aged 6-120 months;
- axillary temperature ≥ 37.5°C and/or history of fever within past 24 hours;
- P. falciparum asexual parasitemia between 1000 and 100000/µl;
- ability to attend follow-up visits.
Key exclusion criteria (7 listed)
- co-infections;
- underlying chronic disease;
- severe malaria as indicated by hyperparasitemia, severe anemia (PCV 15%, Hb 5g/ml), respiratory distress, inability to drink, persistent vomiting in past 24 hours;
- recent history of multiple convulsions;
- jaundice;
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 |
|---|---|---|
| 1. Artemether-Lumefantrine (AL)Also: CoArtemArtemether-Lumefantrine(Co-Artem)=Artemether, 2mg/kg x 2(12h apart) and Lumefantrine, 12mg/kgx2 (12h apart). | Drug | 1 Artemether-Lumefantrine (AL) |
| 2. Amodiaquine-Artesunate (AQ-AS)Also: ArsucamAmodiaquine-Artesunate (0H),D1(24H),D2(48H)= Artesunate 4mg/kg and Amodiaquine at 10mg/kg | Drug | 2 Amodiaquine-Artesunate (AQ-AS) |
Primary outcome
Cure Rate on Day 28
Time frame: Day 0 - 28
To evaluate the safety and antimalarial efficacy of two drug combinations: Artemether-Lumefantrine (AL) and Amodiaquine-Artesunate (AQ - AS) in Camaroonian patients in Mutengene, Bangolan and Garoua
1 secondary outcome
Cure Rate Day 14
Time frame: Day 0-14
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Database available on request of Prof Wilfred Mbacham wfmbacham@yahoo.com
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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 F Mbacham, ScD principal investigator
University of Yaounde
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 1. Artemether-Lumefantrine (AL) and 2. Amodiaquine-Artesunate (AQ-AS) 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 4 inclusion and 7 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 8 Jun 2021. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 8 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cure Rate on Day 28 (time frame: Day 0 - 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 8 Jun 2021.