Monitoring and evaluation of the efficacy and safety of Artesunate-Mefloquine (ASMQ) and Artesunate-Pyronaridine (ASP) for the treatment of uncomplicated Plasmodium falciparum and Plasmodium vivax malaria in Cambodia

Recruiting

• Conditions: Infection - Other infectious diseases; Patients with P. falciparum; Patients with P. vivax

• Registration Number: ACTRN12618001999224
• Lead Sponsor: ational Center for Parasitology, Entomology, and Malaria Control

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-12-13
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Mono-infection with P. falciparum or P. vivax
Axillary above 37.5 Celsius or fever history over the last 24 hours
Ability to swallow oral medication
Ability and willingness to comply with the study for the duration of the study

Exclusion Criteria

Non-malaria febrile
Pregnancy or lactation
Mixed infection or severe malaria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportions of treatment successful confirmed by Polymerase Chain-Reaction (PCR). Three drops of blood will be collected on a filter paper (3M Whatman filter) at day 0 and day of failure to define putative markers related to antimalarial drugs resistance.[28 days post-enrolment for patients with P. vivax malaria and 42 days post-enrolment for patients with P. falciparum malaria <br>]

Secondary Outcome Measures

Name	Time	Method
Proportions of malaria prevalence, drug-induced adverse events such as nausea, vomiting, and dizziness as well as the proportions of other clinical sign and symptoms resulted from the physical examination such as fever, abdominal pain, dark urine, and tachycardia. [Day 0, 1, 2,3]