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MalariaPhase 4NCT00808951

In Vivo and in Vitro Efficacy of Antimalarial Treatments in Children in Burkina Faso

A Phase 4 study testing Artesunate-amodiaquine and Artemether-lumefantrine in people with Malaria, run by Centre Muraz at 1 site in Burkina Faso.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Read more about this study

Who is it for?
Ages 6 months to 15 years
Conditions the study is for
Malaria
What is being tested?
Artesunate-amodiaquine and Artemether-lumefantrine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
440 participants
Where
1 siteBurkina Faso
Study dates
Dec 2008to Feb 2011
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 6 months to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age 6 - 59 months
  • Weight > 5 kg
  • Mono-infection with P. falciparum
  • Parasitemia of 4,000-200,000 asexual parasites per µl
  • Fever: > 37.5 °C or history of fever in the preceding 24 hours
  • Haemoglobin > 5.0 g/dl
  • Signed informed consent by the parents or guardians
  • 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 clinical trial during the previous 30 days
  • Known hypersensitivity to the study drugs
  • Severe and/or complicated malaria (cases will be referred to Bobo-Dioulasso University hospital for treatment)
  • 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;
  • Known intercurrent illness or any condition which would place the subject at undue risk or interfere with the results of the study.
  • Severe malnutrition (weight for height <70% of the median NCHS/WHO reference)

Trial locations and contacts

1 site in 1 country.

Burkina Faso1 site

  • Tinto Halidou

    Bobo-Dioulasso, Houet, 01

Other trials in Burkina Faso

About this study

Official title: In Vivo and in Vitro Efficacy of the Recommended First Line Antimalarial Treatments (Artemether-Lumefantrine and Amodiaquine-Artesunate) in Children With Uncomplicated Malaria in Burkina Faso

Resistance to antimalarial drugs represents a major obstacle for controlling malaria in endemic countries, so that most sub-Saharan countries have changed their antimalarial drug policy to the new Artemisinin Containing Therapies. Burkina Faso has changed its policy for uncomplicated malaria to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS), but there are still little available data on safety and efficacy of these treatments in Burkina Faso; both treatments have shown to be efficacious, but AL seems to have higher occurrence of recurrent malaria infections during a 28-day follow up period. Thus, this study aims at comparing the safety and efficacy of AL and AS-AQ (42-day follow-up), AND also at comparing their in vitro sensitivity, in patients with recurrent infection, with the results obtained in vivo.

Read the detailed description

Plasmodium falciparum resistance to antimalarial drugs represents the major drawback and obstacle for controlling malaria in endemic countries; that's why most sub-Saharan countries have changed their antimalarial drug policy to Artemisinin Containing Therapies (ACT), which produce a rapid clinical and parasitological cure, reduce gametocyte carriage rate and are generally well tolerated. Burkina Faso has recently changed its policy for the treatment of uncomplicated malaria, from Chloroquine to Artemether-Lumefantrine (AL) and Artesunate-Amodiaquine (AQ+AS). However, there are still little available data on safety and efficacy of these treatments in Burkina Faso; a recent study carried out in Bobo Dioulasso showed that both treatments were extremely efficacious (adjusted treatment failure less than 5%) but with AL showing significantly high occurrence of recurrent infections during the 28-day follow up period. The higher risk for recurrent infections for AL was confirmed in a subsequent trial comparing AL with AQ-SP and dihydroartemisinin-piperaquine, but so far no direct comparison between AQ+AS and AL has been completed, though a study in Nanoro, near Ouagadougou, is ongoing. Thus, the present study aims at comparing the in vivo safety and efficacy of AL and AS-AQ (42-day follow-up),AND at comparing the in vitro sensitivity of the different ACT components, in patients with recurrent infection, with the results obtained in vivo.

Conditions
Malaria
Being tested
Artesunate-amodiaquine, Artemether-lumefantrine
Keywords
Uncomplicated malaria, P falciparum, Children, National treatment protocol, Burkina Faso, Artemether-lumefantrine, Artesunate-amodiaquine, In vivo efficacy, In vitro efficacy
Medical subject headings
Malaria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Artesunate-amodiaquineDrug

    Also called ASAQ, Coarsucam

    Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008. It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)

  • Artemether-lumefantrineDrug

    Also called AL, Coartem(R), Riamet(R)

    Artemether-lumefantrine by Novartis was the first fixed-dose ACT that was prequalified by WHO in April 2004. A 3-day, 6-dose regimen of AL is recommended for infants and children weighing 5-35 kg and adults weighing > 35 kg.

Study groups in NCT00808951
Study groupRoleWhat they receive
Artemether -lumefantrineExperimentalTreatment of malaria with Artemether-lumefantrine (AL), according to one of the two options given by national protocol in Burkina Faso
Receives: Drug: Artemether-lumefantrine
Artesunate-amodiaquineExperimentalTreatment of malaria with Artesunate-amodiaquine(AS-AQ), according to one of the two options given by national protocol in Burkina Faso
Receives: Drug: Artesunate-amodiaquine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. PCR unadjusted treatment failure (regardless of genotyping).

    Measured: 42 days

Secondary outcomes (8)

  1. PCR adjusted treatment failure

    Measured: 42 days

  2. PCR unadjusted treatment failure

    Measured: 28 days

  3. PCR adjusted treatment failure

    Measured: 28 days

  4. Fever clearance time

    Measured: day 1, 2, 3

  5. Asexual parasite clearance time

    Measured: day 7, 14, 21, 28, 35, 42

  6. Gametocytaemia (prevalence and density)

    Measured: Day 7, 14, 21, 28, 35 and 42

  7. Safety profiles of the two treatments

    Measured: 42 days overall

  8. Parasites in vitro sensitivity to the drugs tested and their relationship with the in vivo results

    Measured: before treatment and at the day of reccurrente parasitemia

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionOct 2010
  4. Study completionFeb 2011

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
440 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00808951
Sponsor's protocol ID
Malactres-BF
Status last verified
Jul 2015
First submitted
5 Dec 2008
Last updated
3 Aug 2015
Results posted
No
Data monitoring committee
No

Publications

  • Lingani M, Bonkian LN, Yerbanga I, Kazienga A, Valea I, Sorgho H, Ouedraogo JB, Mens PF, Schallig HDFH, Ravinetto R, d'Alessandro U, Tinto H. In vivo/ex vivo efficacy of artemether-lumefantrine and artesunate-amodiaquine as first-line treatment for uncomplicated falciparum malaria in children: an open label randomized controlled trial in Burkina Faso. Malar J. 2020 Jan 6;19(1):8. doi: 10.1186/s12936-019-3089-z.

    PubMed 31906948

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Artesunate-amodiaquine and Artemether-lumefantrine in people with Malaria, run by Centre Muraz at 1 site in Burkina Faso.

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 8 inclusion and 6 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 Aug 2015. 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 Burkina Faso. 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?

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 (regardless of genotyping). (time frame: 42 days). 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 NCT00808951, which also lists 1 linked publication.

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 Aug 2015.

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