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Co-Artemeter in pregnancy - a pilot study (Thailand)
ISRCTN ISRCTN86353884
DOI 10.1186/ISRCTN86353884
ClinicalTrials.gov identifier
EudraCT number
Public title Co-Artemeter in pregnancy - a pilot study (Thailand)
Scientific title
Acronym N/A
Serial number at source RPC043
Study hypothesis That three day Co-Artemeter (artemether-lumefantrine) has a 4% failure rate compared with an estimated 16% failure rate for seven day artesunate (standard treatment).
Lay summary
Ethics approval 1. Ethical Committee of the Faculty of Tropical Medicine, Mahidol University in Bangkok
2. OXTREC (Oxford Tropical Research Ethic Committee)
3. World Health Organization (WHO) Ethics Review Committee
Study design Randomised controlled trial
Countries of recruitment Thailand
Disease/condition/study domain Malaria in pregnancy
Participants - inclusion criteria 1. Pregnant women with uncomplicated falciparum or mixed infection (i.e. Plasmodium falciparum and Plasmodium vivax), symptomatic or not, in the second or third trimester, who have failed after a course of quinine for seven days
2. Willing and able to participate and comply with the study protocol
3. Attend the Shoklo Malaria Research Unit (SMRU) AnteNatal Clinics (ANCs) regularly
4. Agree to deliver at SMRU
Participants - exclusion criteria 1. Splenectomy
2. A known chronic disease (cardiac, renal, hepatic)
3. Known haemoglobinopathy
4. Known hepatic or renal impairment
5. Inability to follow the ANC consultation
6. History of alcohol or narcotic abuse
7. Inability to tolerate oral treatment
8. Severe and complicated malaria
9. Known hypersensitivity to artemisinin derivatives
10. Patient taking any drug inhibiting the cytochrome enzyme CYP3A4 or drug which is metabolised by cytochrome enzyme CYPD or family
11. History of sudden death or of prolongation of QTc interval on electrocardiogram (ECG)
12. Patients with cardiac arrythmia, Congestive Cardiac Failure (CCF), or bradycardia accompanied by reduced left ventricular function
13. Intake of drugs that prolong QTc interval
Anticipated start date 06/02/2004
Anticipated end date 21/01/2008
Status of trial Completed
Patient information material
Target number of participants 250
Interventions Group 1: Artesunate 50 mg tablets (2 mg/kg/day) for seven days
Group 2: Co-artemether (20/120 mg artemether/lumefantrine) four tablets twice a day for three days with 200 ml of chocolate milk at each dose

Please note that the completion of the 12-month follow up of infants born to women enrolled in the study was on 21st January 2008. The previous anticipated end date of this trial was 31/12/2008.
Primary outcome measure(s) Polymerase Chain Reaction (PCR) adjusted parasitological cure, at day 42 or at delivery depending on which occurs last.
Secondary outcome measure(s) Other outcomes include:
1. Gametocyte carriage
2. Pharmacokinetic parameters including the plasma lumefantrine levels at day seven as a marker of absorption as well as the infant development during the first year of life
3. The histo-pathology examination (presence of parasites, pigments, monocytes infiltrations and other placental changes) of the placenta
Sources of funding United Nations Children's Fund (UNICEF)/United Nations Development Programme (UNDP)/World Bank/World Health Organization (WHO) - Special Programme for Research and Training in Tropical Diseases (TDR)
Trial website
Publications 2008 results in http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050253
Contact name Dr  Melba  Gomes
  Address World Health Organization
20 Avenue Appia
  City/town Geneva -27
  Zip/Postcode CH 1211
  Country Switzerland
  Tel +41 (0)22 79 13 813
  Email gomesm@who.int
Sponsor UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
  Address World Health Organization
20 Avenue Appia
  City/town Geneva-27
  Zip/Postcode CH 1211
  Country Switzerland
  Sponsor website: http://www.who.int
Date applied 07/04/2005
Last edited 12/01/2009
Date ISRCTN assigned 07/06/2005
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