Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2025-12-27 @ 9:24 PM
Study NCT ID:
NCT01775592
Status:
COMPLETED
Last Update Posted:
2013-01-28
First Post:
2013-01-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasmodium Falciparum Artemisinin Resistance Vietnam
Sponsor:
National Institute of Malariology, Parasitology and Entomology, Vietnam
Organization:
Study Overview
Official Title:
Monitoring the Efficacy of Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Traleng Commune, Central Vietnam
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.
Detailed Description:
General objective To evaluate the efficacy of DHA-PPQ in patients with uncomplicated falciparum malaria in a rural area of Central Vietnam, and to assess the in vitro susceptibility of P.falciparum isolates to DHA and PPQ.
Specific objectives
1. To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
2. To determine the efficacy of DHA-PPQ at day 42 post-treatment.
3. To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
4. To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;
Specific objectives
1. To measure the parasite clearance time in falciparum malaria patients treated with DHA-PPQ.
2. To determine the efficacy of DHA-PPQ at day 42 post-treatment.
3. To assess the in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province.
4. To compare genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance;
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: