Efficacy and Safety of Pyronaridine-artesunate for the Treatment in Uncomplicated Falciparum Malaria
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|ClinicalTrials.gov Identifier: NCT02389439|
Recruitment Status : Completed
First Posted : March 17, 2015
Last Update Posted : September 20, 2018
This study is a prospective, single arm, open-labelled clinical trial. The total number subjects will be 145 patients to receive Pyronaridine-artesunate once daily for 3 days. Dosing will be according to the body weight.
All patients will have a blood smear examined daily during the first week by microscopy until parasite clearance (2 consecutive negative slides on two consecutive days; both asexual and sexual stages). A negative blood slide will be defined as parasite count negative per 1000 WBC in two consecutive days. The sample on day 3 will be taken as close as possible to 72h after the initial blood smear.
Participant will follow up for 42 days to assess the drug efficacy and safety (Day 7, 14, 21, 28, 35 and 42).
|Condition or disease||Intervention/treatment||Phase|
|Malaria, Falciparum||Drug: Pyronaridine-artesunate||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||123 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Monitoring and Evaluation of the Therapeutic Efficacy and Safety of Pyronaridine-artesunate for the Treatment of Uncomplicated Falciparum Malaria in Western Cambodia, an Area of Artemisinin-resistant Falciparum Malaria|
|Actual Study Start Date :||March 1, 2015|
|Actual Primary Completion Date :||December 1, 2015|
|Actual Study Completion Date :||June 1, 2016|
Pyronaridine-artesunate (Pyramax®, Shin Poong Pharmaceuticals). One tablet contains 60mg artesunate+ 180mg pyronaridine. Dosing will be according to body weight.
It will be taken orally with water, once daily for 3 days. Each dose will be administered under the supervision. A dose will be repeated in full if vomiting occurs within 30 minutes of administration of the first day of administration only.
20 - < 24 kg = 1 tab 24 - < 45 kg = 2 tabs 45 - < 65 kg = 3 tabs 65 and above = 4 tabs
Other Name: Pyramax
- result of PCR [ Time Frame: 42 day ]
- hepatic biological values [ Time Frame: at day 0, 3,7 and day 28 ]the hepatic biological values will be measured which are AST,ALT,albumin and total bilirubin
- eosinophil count [ Time Frame: at day 0, 3, 7 and day 28 ]
- K13 and pfmdr1 of P falciparum resistance [ Time Frame: at day 0, 3, 7 and day 28 ]
- numbers of patients with a positive malaria slide 72 hours after treatment initiation [ Time Frame: 72 hours ]
- fever clearance time [ Time Frame: 24 hours ]the time taken for tympanic temperature to fall below 37.5˚C and remain there for at least 24 hours
- Number of patient with reinfection and recrudescences [ Time Frame: over 42 days ]
- PCR uncorrected ACPR [ Time Frame: at 28 days or 42 days ]PCR uncorrected ACPR at 28 days or 42 days for P. falciparum, P. falciparum and mixed infections in Pailin
- PCR corrected ACPR [ Time Frame: at 28 days and 42 days ]PCR corrected ACPR at 28 days or for P. falciparum, P. vivax and mixed infections and at 42 days for P. falciparum and mixed infections
- Gametocyte carriage rates [ Time Frame: at day 0, 3, 7 day 28 ]
- gametocyte clearance times [ Time Frame: at day 0, 3, 7 and day28 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02389439
|Tasanh Health Centre, Battambang|
|Referral hospital (Pailin)|
|Promoy Health Centre (Pursat)|