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Uncomplicated Falciparum MalariaPhase 4ACTNCT00902811

Effectiveness of Artemisinin Combination Regimens in Falciparum Malaria

A Phase 4 study testing AM(FDC), AM(LT) and AL in people with Uncomplicated Falciparum Malaria, run by Medecins Sans Frontieres, Netherlands at 4 sites in Burma.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region. Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Uncomplicated Falciparum Malaria
What is being tested?
AM(FDC), AM(LT) and AL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
4 sitesBurma
Study dates
Dec 2008to Dec 2009
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 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age over 6 months and
  • Weight ≥ 5 kg, and
  • Slide-confirmed infection with Plasmodium falciparum (including mixed infections), and
  • Asexual parasite density between 500 and 200,000/µl of blood, and
  • Informed consent from a parent or guardian aged at least 18 years.

Who cannot join

  • General danger signs according to the WHO definition or
  • Signs of severe/complicated malaria according to the WHO definition or
  • Severe anaemia (haemoglobin < 5 g/dL), or
  • Known history of hypersensitivity to any of the study drugs, or
  • Severe malnutrition (as defined by a weight-for-height below 70% of median and/or symmetrical oedemas involving at least the feet), or
  • Concomitant febrile illness due to causes other than malaria with the potential to confound study outcome (measles, acute lower tract respiratory infection, otitis media, tonsillitis, abscesses, severe diarrhoea with dehydration, etc.; mild flu should not lead to exclusion) or
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  • History of psychiatric diseases, or
  • Having received a full course treatment including MQ in the preceding 9 weeks or
  • Having received any other antimalarials in the previous 48 hours.

Trial locations and contacts

4 sites in 1 country.

Frank Smithuis, MD contact

frank_smithuis@yahoo.com

Phaikyeong Cheah, PhD contact

phaikyeong@tropmedres.ac

Burma4 sites, 4 recruiting

  • Myit Kyi Nar Clinic

    Kachin

    Mya Nee Nyo, frank_smithuis@yahoo.com

    Mya Nee Nyo, MD

    Recruiting

  • Myothugyi Rural Health Center, Bu Thee Daung

    Maungdaw

    Arkar Linn Naing, frank_smithuis@yahoo.com

    Arkar Linn Naing, MD

    Recruiting

  • Lashio Clinic

    Shan

    Naing Nyo, MD

    Naing Zaw, MD

    Recruiting

  • Dabhine and Mingan Clinic

    Sittwe, Rakhine

    Pyay Phyo Aung, frank_smithuis@yahoo.com

    Pyay Phyo Aung, MD

    Recruiting

Other trials in Burma

About this study

Official title: Comparing the Effectiveness of 5 Artemisinin Combination Treatment Regimens in the Treatment of Uncomplicated Falciparum Malaria

Antimalarial drug resistance is increasing nearly everywhere in the tropical world, confounding global attempts to "Roll Back Malaria." South East Asia has the most resistant malaria parasites in the world. This has limited the options for treatment in this region.

Artemisinin-based combination therapy is now the recommended treatment for uncomplicated falciparum malaria. The success of this policy change in practice will depend on the efficacy of the components of the combination used, the population coverage achieved, high levels of adherence to treatment, low cost of the drugs, and preferably the drugs in a combination treatment should be formulated in a single tablet, to prevent one drug being taken without the partner drug. Until recently there were only two artemisinin-based fixed combinations available, artemether-lumefantrine and dihydroartemisinin-piperaquine; and only the former has international registration. More fixed combinations are needed urgently.

Read the detailed description

Malaria in Myanmar:

In Myanmar, malaria is the number one cause of morbidity. According to the Department of Health (DoH) and WHO there are approximately 500,000 patients with malaria each year. About 80% of reported infections are due to Plasmodium falciparum and 20% are due to Plasmodium vivax. This is likely to be a severe underestimation. MSF-Holland alone treats already 250,000 slide positive malaria patients per year in an area of mixed endemicity covering a population of less that 1 million patients out of a total population of 54 million in the country.

Chloroquine was the first line treatment for falciparum malaria for the last five decades. In 1996 and 1998 MSF-Holland with support from the Wellcome Trust (Prof N. White) performed studies in the northern and western part of the country, in which very high in-vivo resistance levels to chloroquine and sulfadoxine-pyrimethamine were demonstrated1,2. Combination treatment of mefloquine plus artesunate (loose tablets) [MA(LT)]and treatment with dihydroartemisinin-piperaquine (DP) both proved highly efficacious (99-100%)3,4. The studies performed by MSF provided an important component of the evidence used to convince the health authorities that a change of national protocol was needed. In 2001, the DOH of Myanmar changed the national protocol for the treatment of uncomplicated falciparum malaria; a 3 day treatment of mefloquine-artesunate was chosen to become the first line treatment. Artemether-lumefantrine (AL) and DP are also mentioned in the national protocol as effective treatment regimens, but there is a call in the protocol for more research of these treatments.

These changes in policy are a very good step forward and were widely respected. In practice, some problems remain.

MSF has implemented large malaria activities in Myanmar over the past decade. The programme has performed a diagnostic test for malaria for approximately 3,000,000 patients and approximately 1,500,000 patients have been treated with artemisinin combination treatment (ACT).

Being tested
AM(FDC), AM(LT), AL, DP, AA(FDC)
Keywords
uncomplicated falciparum malaria, artemisinin combination therapy

What participants receive

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

  • AM(FDC)Drug

    Also called Far-Manguinhos, Brazil

    Artesunate-mefloquine fixed dose combination (artesunate 25mg/mefloquine hydrochloride 55mg, or artesunate 100mg/mefloquine hydrochloride 220mg), according to age-group.

  • AM(LT)Drug

    Also called Lariam®, Roche

    Artesunate (Arsumax®, Sanofi) 50 mg tabs given at 4 mg/Kg/day on day 0, day 1 and day 2 (total 12 mg/Kg) PLUS Mefloquine 250 mg base tabs given at 25 mg/Kg on day 0. Treatment is given in three equally divided daily doses to the nearest quarter tablet.

  • ALDrug

    Also called Coartem®

    Coartem®: artemether 20 mg - lumefantrine 120 mg co-formulated tabs (Coartem®, Novartis) given as six twice-daily doses over three days, according to weight-groups. The second dose should be taken 6 to 10 hours after the first dose, given at inclusion. Patients will be advised to take some fatty food (or encouraged to give breast feeding) before each dose is taken. Fatty food or milk will not be provided by the researchers.

  • DPDrug

    Also called DuoCotecxin, Holley Pharm

    40 mg dihydroartemisinin/320 mg piperaquine tablets and Dihydropiperaquine 20mg/ Piperaquine 160 mg tablets),. Treatment is given according to age groups. In the age group <6yrs of age, a subdivision according to weight is made

  • AA(FDC)Drug

    Also called Artesunate Amodiaquine Winthrop® Sanofi Aventis

    Artesunate-amodiaquine fixed dose combination (FDC) (Artesunate Amodiaquine Winthrop® Sanofi Aventis); Artesunate 25mg/amodiaquine 67.5mg; Artesunate 50mg/amodiaquine 135mg ; Artesunate 100mg/amodiaquine 270mg

Study groups in NCT00902811
Study groupRoleWhat they receive
AM(LT)Active comparatorArtesunate (Arsumax®, Sanofi)
Receives: Drug: AM(LT)
AM(FDC)ExperimentalArtesunate-mefloquine fixed dose combination
Receives: Drug: AM(FDC)
ALExperimentalartemether 20 mg - lumefantrine 120 mg co-formulated tabs
Receives: Drug: AL
DPExperimental40 mg dihydroartemisinin/320 mg piperaquine tablets and Dihydropiperaquine 20mg/Piperaquine 160 mg tablets
Receives: Drug: DP
AA (FDC)ExperimentalArtesunate-amodiaquine fixed dose combination
Receives: Drug: AA(FDC)

What is being measured

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

  1. Cure rate

    Measured: 63 days

Secondary outcomes (3)

  1. Early treatment failure

    Measured: Day 6

  2. Late treatment failure

    Measured: Day 63

  3. Adequate response

    Measured: Day 63

Timeline

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

  1. First posted15 May 2009 (estimated)
  2. Study startDec 2008
  3. Primary completionOct 2009 (estimated)
  4. Study completionDec 2009 (estimated)

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00902811
Sponsor's protocol ID
YNG0901
Acronym
ACT
Status last verified
May 2009
First submitted
30 Apr 2009
Last updated
15 May 2009
Results posted
No
Data monitoring committee
No

Publications

  • Smithuis F, Kyaw MK, Phe O, Win T, Aung PP, Oo AP, Naing AL, Nyo MY, Myint NZ, Imwong M, Ashley E, Lee SJ, White NJ. Effectiveness of five artemisinin combination regimens with or without primaquine in uncomplicated falciparum malaria: an open-label randomised trial. Lancet Infect Dis. 2010 Oct;10(10):673-81. doi: 10.1016/S1473-3099(10)70187-0. Epub 2010 Sep 9.

    PubMed 20832366

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing AM(FDC), AM(LT) and AL in people with Uncomplicated Falciparum Malaria, run by Medecins Sans Frontieres, Netherlands at 4 sites in Burma.

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 5 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 15 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Burma. 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 Frank Smithuis, MD (frank_smithuis@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cure rate (time frame: 63 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 NCT00902811, 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 15 May 2009.

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