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23 May 2012
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| [ Print-friendly version ] |
| Co-Artemeter in pregnancy - a pilot study (Thailand) |
| ISRCTN | ISRCTN86353884 |
| ClinicalTrials.gov identifier | |
| 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 |
| 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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