Co-Artemeter in pregnancy - a pilot study (Thailand)

ISRCTN	ISRCTN86353884
DOI	https://doi.org/10.1186/ISRCTN86353884
Protocol serial number	RPC043
Sponsor	UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Funder	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)

Submission date: 07/04/2005
Registration date: 07/06/2005
Last edited: 12/01/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Melba Gomes
Scientific

World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland

Phone	+41 (0)22 79 13 813
Email	gomesm@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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).
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Malaria in pregnancy
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Co-Artemeter (artemether-lumefantrine), artesunate.
Primary outcome measure(s)	Polymerase Chain Reaction (PCR) adjusted parasitological cure, at day 42 or at delivery depending on which occurs last.
Key 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
Completion date	21/01/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	250
Key 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
Key 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
Date of first enrolment	06/02/2004
Date of final enrolment	21/01/2008

Locations

Countries of recruitment

Switzerland
Thailand

Study participating centre

World Health Organization

Geneva -27
CH 1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	23/12/2008		Yes	No