P. Falciparum Resistance to Artemisinin in Vietnam

• Register: ClinicalTrials.gov
• Last refreshed on: 28 December 2015
• Main ID: NCT02604966
• Date of registration: 24/10/2015
• Prospective Registration: No
• Primary sponsor: National Institute of Malariology, Parasitology and Entomology, Vietnam
• Public title: P. Falciparum Resistance to Artemisinin in Vietnam
• Scientific title: Efficacy of Artesunate Monotherapy and Dihydroartemisinin - Piperaquine in Patients With Uncomplicated Falciparum Malaria in Central Vietnam
• Date of first enrolment: April 2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02604966
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Vietnam

Contacts

• Name: Duong Tran, MD, PhD
• Affiliation: National Institute of Malariology, Parasitology and Entomology, Hanoi, Vietnam

• Name: Anna Rosanas-Urgell, MD, PhD
• Affiliation: Institute of Tropical Medicine, Antwerp, Belgium

• Name: Phuc Bui, MD, PhD

• Name: Phuc Bui, MD, PhD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Mono-infection with P. falciparum;

- Parasite density (trophozoites) between 500-100,000/µl;

- Fever (axillary temperature 37.5C) or history of fever in the previous 24h.;

- Ability to swallow oral medication;

- Ability and willingness to comply with the study protocol and with the study visit
schedule;

- Written informed consent/assent to participate to the trial.

Exclusion Criteria:

- Mixed or mono-infection with another Plasmodium species confirmed by microscopy;

- General danger signs or symptoms of severe malaria according to WHO definitions;

- Signs or symptoms of severe malnutrition (weight-for-age = 3 standard deviations
below the mean (NCHS/WHO normalized reference values));

- Anaemia (Hb <7g/dl in adults (<5g/dl in children));

- Pregnancy or lactation (urine test for ß HCG);

- Concomitant acute illness necessitating specific treatment (antibiotics);

- Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS);

- Known hypersensitivity to any of the drugs being evaluated;

- Regular use of medication that may interfere with antimalaria pharmacokinetics



Age minimum: 1 Year
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Drug Resistant Malaria Due to Plasmodium Falciparum

Intervention(s)

Drug: DHA - PPQ group

Drug: Artesunate (AS) group

Primary Outcome(s)

Median parasite clearance time after treatment with Artesunate or with DHA - PIP [Time Frame: From time of first treatment dose (day0 hh-mm) until day and time of parasite clearance (=two consecutive blood samples are found negative for parasites) assessed up day 42]

Secondary Outcome(s)

Number of patients with Adequate Clinical and Parasitological Response (ACPR) to DHA-PPQ for the treatment for uncomplicated P falciparum malaria infections in central Vietnam. [Time Frame: From day0 to day 42]

Secondary ID(s)

NIMPE - ITM- P.f

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Institute of Tropical Medicine, Belgium