Routine monitoring and evaluation of efficacy and safety of artesunate-mefloquine (ASMQ) in Pailin, and dihydroartemisinin-piperaquine (DP) in Pursat, Kratie, and Preah Vihear for the treatment of uncomplicated Plasmodium falciparum malaria, Cambodia 2011

Phase 4

Active, not recruiting

• Conditions: Infection - Other infectious diseases; Malaria

• Registration Number: ACTRN12612000182897
• Lead Sponsor: Global Fund For Malaria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-02-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Equal to or greater than 2 years old;
-Mono Infection with P. falciparum;
-Parasitaemia, 500–200 000 asexual forms per microlitre for P.f;
-Axillary temperature greater than 37.5 degree C
-Ability to swallow oral medication;
-Ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule;
-Informed consent from the patient or from a parent or guardian in case of children.

Exclusion Criteria

-Unmarried females aged 12-18 years old
-Presence of general danger signs among children <5 years old or other signs of severe and complicated falciparum malaria according to current WHO definitions;
-Mixed species;
-Presence of febrile conditions due to diseases other than malaria (measles, acute lower tract respiratory infection, severe diarrhea with dehydration, etc.),
-Known hypersensitivity or allergy to artesunate or mefloquine
-Known psychiatric disorders, e.g. depression or epilepsy
-Anti arrhythmic or others drugs which are known to influence cardiac function

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
42-day cure rate or ACPR (adequate clinical and parasitological response for falciparum cases<br>42-day PCR-corrected ACPR (PCR: polymerase chain reaction, a molecular tool/test to differentiate if the failure is a true resistance or reinfection) for falciparum cases only[at the end of 42-day follow up for falciparum cases]

Secondary Outcome Measures

Name	Time	Method
Reported signs and symptoms of adverse effects during the time of drug administration were collected in the case record form. The patients may experience the following adverse effect.<br><br>1 Dizziness <br>2 Headache <br>3 Vestige <br>4 Nausea<br>5 Vomiting<br>6 Diarrhea<br>7 Abdomen pain <br>8 Dark Urine[first 3 days after drug administration]