Co-Artemeter in pregnancy - a pilot study (Thailand)
| ISRCTN | ISRCTN86353884 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86353884 |
| Secondary identifying numbers | RPC043 |
- 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
Scientific
World Health Organization
20 Avenue Appia
Geneva -27
CH 1211
Switzerland
| Phone | +41 (0)22 79 13 813 |
|---|---|
| gomesm@who.int |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Co-Artemeter (artemether-lumefantrine), artesunate. |
| Primary outcome measure | 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 study start date | 06/02/2004 |
| Completion date | 21/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
CH 1211
Switzerland
Sponsor information
UNICEF/UNDP/World Bank/WHO - Special Programme for Research and Training in Tropical Diseases (TDR)
Research organisation
Research organisation
World Health Organization
20 Avenue Appia
Geneva-27
CH 1211
Switzerland
| Website | http://www.who.int |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
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)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
