Condition category
Infections and Infestations
Date applied
07/04/2005
Date assigned
07/06/2005
Last edited
12/01/2009
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 Melba Gomes

ORCID ID

Contact details

World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland
+41 (0)22 79 13 813
gomesm@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC043

Study information

Scientific title

Acronym

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).

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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 names

Co-Artemeter (artemether-lumefantrine), artesunate.

Primary outcome measures

Polymerase Chain Reaction (PCR) adjusted parasitological cure, at day 42 or at delivery depending on which occurs last.

Secondary outcome measures

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

Overall trial start date

06/02/2004

Overall trial end date

21/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

250

Participant 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

Recruitment start date

06/02/2004

Recruitment end date

21/01/2008

Locations

Countries of recruitment

Thailand

Trial participating centre

World Health Organization
Geneva -27
CH 1211
Switzerland

Sponsor information

Organisation

UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)

Sponsor details

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

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Research organisation

Funder name

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)

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

2008 results in http://medicine.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pmed.0050253

Publication citations

Additional files

Editorial Notes