FeverPhase 3NCT00393679
Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
A Phase 3 study testing amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ) and artemether-lumefantrine (AL) in people with Fever and Malaria, run by Institute of Tropical Medicine, Belgium at 8 sites in 7 countries.
Trial summary
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Read more about this study
- Who is it for?
- Ages 6 to 59 months
- What is being tested?
- amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ) and artemether-lumefantrine (AL)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,112 participants
- Where
- 8 sitesin 7 countries
- Study dates
- Jul 2007to Dec 2009
- Phase
- Phase 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
- Males and Females aged between 6 months and 59 months inclusive. In the sites where CDA is tested all recruited children will be aged between 12 months and 59 months inclusive (this arm was discontinued on 17th February 2008). This criterion applies only for the recruitment in the first follow up. For the second follow up, children having been included in the first follow up are eligible, regardless of their age.
- Body weight of 5 Kg and above.
- Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia ≥ 2,000/μL to 200,000/μL).
- Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
- Haemoglobin value ≥ 7.0 g/dl;
- Signed (or thumb-printed whenever parents/guardians are illiterate) informed consent by the parents or guardians. Note the informed consent will be asked only at recruitment and will cover the whole period of the study, including second active follow up and passive case detection.
- Parents' or guardians' willingness and ability to comply with the study protocol for the duration of the trial.
Who cannot join
- Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
- Known hypersensitivity to the study drugs.
- Severe malaria.
- Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand.
- Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
- Severe malnutrition (defined as weight for height <70% of the median NCHS/WHO reference).
- Ongoing prophylaxis with drugs having antimalarial activity such as cotrimoxazole for the prevention of Pneumocystis carinii pneumonia in children born to HIV+ women.
Trial locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
About this study
The main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms.
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008.
TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.
- Being tested
- amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL), Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)
- Keywords
- Children 6-59 months, P.falciparum, Haemoglobin, Informed consent, ACT
- Medical subject headings
- Fever, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amodiaquine-artesunate (ASAQ)Drug
Also called Coarsucam by Sanofi-Aventis
A fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg
dihydroartemisinin-piperaquine (DHAPQ)Drug
Also called Artekin, Eurartekin by Sigma Tau, NOTE: batches expire on 31Oct08. Due to unavailability of new batches, recruitment in this arm was discontinued on 30Oct08.
DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively.
artemether-lumefantrine (AL)Drug
Also called Coartem, Riamet by Novartis
Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine.
Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)Drug
Also called Lapdap by GSK., Arsumax by Sanofi and Guilin.
Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate.
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AS-AQ Receives: Drug: amodiaquine-artesunate (ASAQ) |
| 2 | Experimental | DHAPQ
TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. Receives: Drug: dihydroartemisinin-piperaquine (DHAPQ) |
| 3 | Experimental | AL Receives: Drug: artemether-lumefantrine (AL) |
| 4 | Experimental | Lapdap + AS
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008. Receives: Drug: Lapdap (Chlorproguanil-Dapsone) + artesunate (AS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping.
Measured: Day 28
PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence.
Measured: Day 28
Secondary outcomes (11)
PCR unadjusted treatment failure up to day 63 (TF63U): TF28U plus all cases of recurrent parasitaemia (symptomatic or asymptomatic) detected between day 29 and day 63 by passive follow up, regardless of genotyping
Measured: Day 63
PCR adjusted treatment failure for the whole period of passive surveillance (TFAPS): TF28A plus all episodes of recurrent parasitaemia identified as recrudescence by genotyping.
Measured: Day 28
Fever clearance time.
Asexual parasite clearance time.
Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment (for both active follow-ups);
Measured: 28 days
Hb changes day 3, 7, 14 and 28 (first and second follow up);
Measured: 28 days
Clinical malaria after first active follow-up;
Measured: 28 Days
Clinical malaria after second active follow-up;
Measured: Up to seven months
TF second clinical episode (D28 and D63);
Measured: 63 days
Changes in the frequency of mutations in the dihydrofolate reductase (DHFR) gene at day 0 first follow-up and day re-appearance of parasitaemia (for patients treated with CDA - NOTE that CDA arm was discontinued on 17.02.2008).
Safety profiles including significant changes in relevant laboratory values.
Measured: Up to seven months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startJul 2007
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FeverStudies 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
- None (open label)
- Enrolment
- 4,112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Tropical Medicine, Belgium
- Sponsor type
- University, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, East African Network for Monitoring Antimalarial Treatment, Centre Muraz, University of Calabar, Tropical Diseases Research Centre, Zambia, University Hospital Tuebingen, Albert Schweitzer Hospital, Uganda Malaria Surveillance Project, Mbarara University of Science and Technology, Ministry of Health, Rwanda, University of Barcelona, Centro de Investigacao em Saude de Manhica
- Responsible party
- Sponsor
- Investigators
- UmbertoC D'Alessandro, MD MsC PhD, Study director, Institute of Tropical Medicine Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393679
- Sponsor's protocol ID
- 4 ABC
- Other IDs
- IRB Antwerp: 6/40/187
- Status last verified
- Jan 2014
- First submitted
- 27 Oct 2006
- Last updated
- 3 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ravinetto RM, Talisuna A, De Crop M, van Loen H, Menten J, Van Overmeir C, Tinto H, Gonzalez R, Meremikwu M, Nabasuma C, Ngoma GM, Karema C, Adoke Y, Chaponda M, Van Geertruyden JP, D'Alessandro U. Challenges of non-commercial multicentre North-South collaborative clinical trials. Trop Med Int Health. 2013 Feb;18(2):237-41. doi: 10.1111/tmi.12036. Epub 2012 Dec 10.
PubMed 23217117Four Artemisinin-Based Combinations (4ABC) Study Group. A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. PLoS Med. 2011 Nov;8(11):e1001119. doi: 10.1371/journal.pmed.1001119. Epub 2011 Nov 8.
PubMed 22087077
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of 4 Artemisinin-based Combinations for Treating Uncomplicated Malaria in African Children
- ClinicalTrials.gov ID
- NCT00393679
- Acronym / sponsor ID
- 4 ABC
- Keywords
- Children 6-59 months, P.falciparum, Haemoglobin, Informed consent, ACT
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,112 participants (actual)
- Lead sponsor
- Institute of Tropical Medicine, BelgiumUniversity, hospital or other
- Collaborators
- Liverpool School of Tropical Medicine, East African Network for Monitoring Antimalarial Treatment, Centre Muraz, University of Calabar, Tropical Diseases Research Centre, Zambia, University Hospital Tuebingen, Albert Schweitzer Hospital, Uganda Malaria Surveillance Project, Mbarara University of Science and Technology, Ministry of Health, Rwanda, University of Barcelona, Centro de Investigacao em Saude de Manhica
- Study start
- Jul 2007
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 30 Oct 2006 (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 main objective is to compare the safety and efficacy of 4 artemisinin-based combinations (ACT) [amodiaquine-artesunate (AQ+AS), dihydroartemisinin-piperaquine (DHAPQ), artemether-lumefantrine (AL) and chlorproguanil/dapsone plus artesunate] for single and repeat treatments of uncomplicated malaria in children. Safety will be determined by registering adverse events and grading, laboratory, and vital signs evaluations. Their incidence will be compared between the different study arms.
TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. The leading EC approved the amendment on 2nd June 2008.
TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: amodiaquine-artesunate (ASAQ)AS-AQ |
| 2 | Experimental | Drug: dihydroartemisinin-piperaquine (DHAPQ)DHAPQ TO BE NOTED: since the batches of the study drug DHAPQ expire at the end of October 2008, and because of the unavailability of a new batch of DHAPQ from the manufacturer, the recruitment in the DHAPQ arm had to be discontinued on 30th October 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities. |
| 3 | Experimental | Drug: artemether-lumefantrine (AL)AL |
| 4 | Experimental | Drug: Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)Lapdap + AS TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008. |
Who may qualify
- Ages
- 6 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Males and Females aged between 6 months and 59 months inclusive. In the sites where CDA is tested all recruited children will be aged between 12 months and 59 months inclusive (this arm was discontinued on 17th February 2008). This criterion applies only for the recruitment in the first follow up. For the second follow up, children having been included in the first follow up are eligible, regardless of their age.
- Body weight of 5 Kg and above.
- Microscopically confirmed, monoinfection of Plasmodium falciparum (parasitaemia ≥ 2,000/μL to 200,000/μL).
- Fever (axillary temperature at ≥ 37.5°C) or history of fever in the previous 24 hours.
- Haemoglobin value ≥ 7.0 g/dl;
Key exclusion criteria (7 listed)
- Participation in any other investigational drug study (antimalarial or others) during the previous 30 days.
- Known hypersensitivity to the study drugs.
- Severe malaria.
- Danger signs: not able to drink or breast-feed, vomiting (> twice in 24hours), recent history of convulsions (>1 in 24h), unconscious state, unable to sit or stand.
- Presence of intercurrent illness or any condition (cardiac, renal, hepatic diseases) which in the judgement of the investigator would place the subject at undue risk or interfere with the results of the study, including known G6PD deficiency.
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-artesunate (ASAQ)Also: Coarsucam by Sanofi-AventisA fix-dose combination tablet containing artesunate-amodiaquine in three different dosages, to be used according to patient age and weight: 25mg/67.5mg; 50mg/135mg; 100mg/270mg | Drug | 1 |
| dihydroartemisinin-piperaquine (DHAPQ)Also: Artekin, Eurartekin by Sigma Tau, NOTE: batches expire on 31Oct08. Due to unavailability of new batches, recruitment in this arm was discontinued on 30Oct08.DHAPQ tablets contain either 20/160mg or 40/320mg of dihydroartemisinin (DHA) and piperaquine phosphate (PQ) respectively. | Drug | 2 |
| artemether-lumefantrine (AL)Also: Coartem, Riamet by NovartisTablets containing 20 mg of Artemether and 120 mg of Lumefantrine. | Drug | 3 |
| Lapdap (Chlorproguanil-Dapsone) + artesunate (AS)Also: Lapdap by GSK., Arsumax by Sanofi and Guilin.Lapdap tablets contain 15/18.75mg or 80/100mg of Chlorproguanil Hydrochloride and Dapsone, respectively. Arsumax® tablets contain 50mg Artesunate. TO BE NOTED: following GlaxoSmithKline decision to discontinue the clinical development of the fixed-doses combination of Lapdap (Chlorproguanil-Dapsone) and artesunate, the Lapdap plus Artesunate arm was immediately discontinued in this study, on 17th February 2008. A formal amendment has been submitted to all the concerned ECs and competent authorities.The leading EC approval was obtained on 2nd June 2008. | Drug | 4 |
Primary outcome
PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping.
Time frame: Day 28
PCR adjusted treatment failure up to day 28 (TF28A): all early failures before day 14 plus the recurrent parasitaemias detected at day 14 or later and classified by genotyping as recrudescence.
Time frame: Day 28
11 secondary outcomes
PCR unadjusted treatment failure up to day 63 (TF63U): TF28U plus all cases of recurrent parasitaemia (symptomatic or asymptomatic) detected between day 29 and day 63 by passive follow up, regardless of genotyping
Time frame: Day 63
PCR adjusted treatment failure for the whole period of passive surveillance (TFAPS): TF28A plus all episodes of recurrent parasitaemia identified as recrudescence by genotyping.
Time frame: Day 28
Fever clearance time.
Asexual parasite clearance time.
Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment (for both active follow-ups);
Time frame: 28 days
Hb changes day 3, 7, 14 and 28 (first and second follow up);
Time frame: 28 days
Clinical malaria after first active follow-up;
Time frame: 28 Days
Clinical malaria after second active follow-up;
Time frame: Up to seven months
TF second clinical episode (D28 and D63);
Time frame: 63 days
Changes in the frequency of mutations in the dihydrofolate reductase (DHFR) gene at day 0 first follow-up and day re-appearance of parasitaemia (for patients treated with CDA - NOTE that CDA arm was discontinued on 17.02.2008).
Safety profiles including significant changes in relevant laboratory values.
Time frame: Up to seven months
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 3 Feb 2014.
- Background: PubMed 23217117Ravinetto RM, Talisuna A, De Crop M, van Loen H, Menten J, Van Overmeir C, Tinto H, Gonzalez R, Meremikwu M, Nabasuma C, Ngoma GM, Karema C, Adoke Y, Chaponda M, Van Geertruyden JP, D'Alessandro U. Challenges of non-commercial multicentre North-South collaborative clinical trials. Trop Med Int Health. 2013 Feb;18(2):237-41. doi: 10.1111/tmi.12036. Epub 2012 Dec 10.
- Results publication: PubMed 22087077Four Artemisinin-Based Combinations (4ABC) Study Group. A head-to-head comparison of four artemisinin-based combinations for treating uncomplicated malaria in African children: a randomized trial. PLoS Med. 2011 Nov;8(11):e1001119. doi: 10.1371/journal.pmed.1001119. Epub 2011 Nov 8.
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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.
UmbertoC D'Alessandro, MD MsC PhD study director
Institute of Tropical Medicine Antwerp
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing amodiaquine-artesunate (ASAQ), dihydroartemisinin-piperaquine (DHAPQ) and artemether-lumefantrine (AL) in people with Fever and Malaria, run by Institute of Tropical Medicine, Belgium at 8 sites in 7 countries.
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 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 3 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Uganda, Burkina Faso, Gabon, Mozambique, Nigeria and 2 more countries. 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 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?
PCR unadjusted treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping. (time frame: Day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393679, which also lists 2 linked publications.
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 3 Feb 2014.