Condition category
Infections and Infestations
Date applied
24/12/2005
Date assigned
24/04/2006
Last edited
06/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Frank Smithuis

ORCID ID

Contact details

Thanlwin Road 62 A
Yangon
-
Myanmar
+95 1 534679
msfh_yangon@mptmail.net.mm

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Non-inferiority of efficacy and effectiveness of dihydroartemisinin-piperaquine compared to mefloquine-artesunate for the treatment of uncomplicated falciparum malaria in adults and children in western Myanmar.

Ethics approval

Approved by Doctors Without Borders (Medecins sans Frontieres [MSF]) Ethical Review Board on 05/12/2003

Study design

An open randomised comparison

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Falciparum malaria

Intervention

Comparison of two different treatment regimes: dihydroartemisinin-piperaquine and mefloquine-artesunate. Both treatment regimes were given observed or not observed; total of four study groups.

Intervention type

Drug

Phase

Not Specified

Drug names

Dihydroartemisinin-piperaquine and artesunate-mefloquine

Primary outcome measures

Polymerase chain reaction (PCR) adjusted parasitological failure rates by day 42

Secondary outcome measures

1. Vivax appearances
2. Gametocytaemia (person gametocyte weeks between day 0 and 42)
3. Whole blood piperaquine levels at day 7
4. Adverse effects

Overall trial start date

08/12/2003

Overall trial end date

30/03/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with fever (axillary temperature >37.5°C), or a history of fever within 48 hours
2. Confirmed falciparum malaria (mixed infection P. falciparum with P. vivax and/or P. malariae were included), with more than 500 but less than 100,000 asexual parasites per ml

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

640

Participant exclusion criteria

1. Signs of severe and complicated malaria
2. Children below one-year-old
3. Pregnant women
4. Patients with a history of taking mefloquine during the previous two months
5. Patients taken any other antimalarial drugs in the previous 48 hours
6. Patients with a history of psychiatric diseases

Recruitment start date

08/12/2003

Recruitment end date

30/03/2004

Locations

Countries of recruitment

Myanmar

Trial participating centre

Thanlwin Road 62 A
Yangon
-
Myanmar

Sponsor information

Organisation

Doctors Without Borders (Medecins sans Frontieres [MSF]) (The Netherlands)

Sponsor details

Plantage Middenlaan 14
Amsterdam
1018DD
Netherlands
+31 (0)20 5208700
info@amsterdam.msf.org

Sponsor type

Charity

Website

http://www.artsenzondergrenzen.nl

Funders

Funder type

Charity

Funder name

Internally funded by Doctors Without Borders (Artsen zonder Grenzen MSF) (Holland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=Abstract&list_uids=16798391

Publication citations

  1. Results

    Smithuis F, Kyaw MK, Phe O, Aye KZ, Htet L, Barends M, Lindegardh N, Singtoroj T, Ashley E, Lwin S, Stepniewska K, White NJ, Efficacy and effectiveness of dihydroartemisinin-piperaquine versus artesunate-mefloquine in falciparum malaria: an open-label randomised comparison., Lancet, 2006, 367, 9528, 2075-2085, doi: 10.1016/S0140-6736(06)68931-9.

Additional files

Editorial Notes