Efficacy, Safety, and Tolerability of Dihydroartemisinin-piperaquine + Mefloquine Compared to Dihydroartemisinin-piperaquine or Artesunate-mefloquine in Patients With Uncomplicated Falciparum Malaria in Cambodia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02612545
• Date of registration: 20/11/2015
• Prospective Registration: Yes
• Primary sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Public title: Efficacy, Safety, and Tolerability of Dihydroartemisinin-piperaquine + Mefloquine Compared to Dihydroartemisinin-piperaquine or Artesunate-mefloquine in Patients With Uncomplicated Falciparum Malaria in Cambodia
• Scientific title: A Multi-Site, Open-Label, Randomized Trial to Assess the Efficacy, Safety, and Tolerability of Dihydroartemisinin-Piperaquine Plus Mefloquine Compared to Dihydroartemisinin-Piperaquine or Artesunate-Mefloquine in Patients With Uncomplicated Falciparum Malaria in Cambodia
• Date of first enrolment: November 20, 2015
• Target sample size: 216
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02612545
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Cambodia

Contacts

• Name: Thomas E Wellems, M.D.
• Affiliation: National Institute of Allergy and Infectious Diseases (NIAID)

Key inclusion & exclusion criteria

- INCLUSION:

- Age 2 to 65 years

- Uncomplicated falciparum malaria, confirmed by the presence of asexual P.falciparum
parasites (alone or mixed with other Plasmodium species) on blood film

- Asexual P. falciparum count <200,000/ L at screening

- Tympanic temperature greater than or equal to 37.5 (Infinite)C or history of fever in
the previous 24 hours

- Written informed consent from adults or the parents/guardians of children

EXCLUSION:

- Signs of severe malaria, defined as one or more of the following:

- Glasgow Coma Scale less than or equal to 10/15 in adults; Blantyre Coma Scale less
than or equal to 3/5 in children

- Witnessed convulsions

- Severe prostration

- Shock (poor perfusion, cool peripheries as deemed by the study physician)

- Hematocrit <20%

- Jaundice

- Respiratory distress (labored breathing, nasal flaring, intercostal retraction)

- Anuria for 24 hours or more

- Repetitive vomiting

- Hematocrit <25%

- Acute illness other than uncomplicated falciparum malaria requiring treatment

- Pregnancy or breastfeeding

- Patients who have received an ART derivative or ACT in the previous 7 days

- Treatment with MQ in the previous 60 days

- History of allergy or known contraindication to ART, PPQ, MQ, or PMQ

- Splenectomy

- Documented or claimed history of cardiac arrythmias, neuropsychiatric disease

- Earlier participation in this trial

- Any condition that in the opinion of the investigator would render the patient unable
to comply with the protocol (e.g., psychiatric disease)

- Any health condition that in the opinion of the investigator would confound data
analysis (e.g., patients known to be HIV-infected or to have AIDS) or pose unnecessary
exposure risks to the patient (e.g., severe malnutrition)



Age minimum: 2 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acute Falciparum Malaria

Intervention(s)

Drug: Dihydroartemisinin-piperaquine (DHA-PPQ)

Drug: Mefloquine (MQ)

Primary Outcome(s)

Compare the efficacy of TACT versus ACT, as defined by an adequate clinical and parasitological response (ACPR), defined as: absence of parasitemia on Day 42 (detected by blood smear, not PCR), irrespective of tympanic temperature, in subjects w... [Time Frame: Day 42 post enrollment]

Secondary Outcome(s)

Compare ECG QTc prolongation following TACT versus ACT [Time Frame: Days 0-2 post enrollment]

Compare the safety and tolerability of TACT versus ACT [Time Frame: Day 0-6 post enrollment]

Compare parasite and fever clearance rates/times following TACT versus ACT [Time Frame: Days 0-6 post enrollment]

Secondary ID(s)

16-I-N023

999916023

Source(s) of Monetary Support

Please refer to primary and secondary sponsors