Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases
Palabras clave
Abstracto
Descripción
The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.
The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.
Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.
All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:
fechas
| Verificado por última vez: | 07/31/2008 |
| Primero enviado: | 06/23/2011 |
| Inscripción estimada enviada: | 07/07/2011 |
| Publicado por primera vez: | 07/11/2011 |
| Última actualización enviada: | 07/07/2011 |
| Última actualización publicada: | 07/11/2011 |
| Fecha de inicio real del estudio: | 11/30/2008 |
| Fecha estimada de finalización primaria: | 02/28/2010 |
| Fecha estimada de finalización del estudio: | 09/30/2010 |
Condición o enfermedad
Intervención / tratamiento
Drug: dihydroartemisinin-piperaquine
Drug: Dihydroartemisininpiperaquine primaquine
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: dihydroartemisinin-piperaquine | Drug: dihydroartemisinin-piperaquine This study used fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine for each tablet (D-ARTEPP®, Guilin Pharmaceutical Co., Ltd, China. The regimen is based on weight for 3 days (D0, D1 and D2) with maximal dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg. |
| Active Comparator: Dihydroartemisininpiperaquine primaquine | Drug: Dihydroartemisininpiperaquine primaquine For DHP, treatment was as for Arm dihydroartemisinin piperaquine. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets (local product by PT Pharos Indonesia, batch no 15306002, produced on 30/05/2008 and expiring on May 2012). The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets. |
Criterio de elegibilidad
| Edades elegibles para estudiar | 4 Years A 4 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: - age ≥ 4 years old - parasite count ≥ 1,000 asexual parasites/µL - normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA) - hemoglobin level ≥ 8 gr/dL as measured by Hemoque® apparatus; - have the ability to return for 42-day-follow up and - willingness to sign the informed-consent form. Exclusion Criteria: - are infected with other r plasmodium species - have only gametocytes of P. falciparum; - are pregnant - measured by positive result on HCG urine test and/or breastfeeding women - present signs of pitting edema on both legs as a sign of malnutrition - have complicated or severe malaria, other chronic diseases or history of drug allergies. |
Salir
Medidas de resultado primarias
1. Development of sexual stages of P.falciparum [42 days post treatment]
Medidas de resultado secundarias
1. Clearance of asexual stages P.falciparum [42 days post treatment]
