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

• Status: Completed
• Trial end date: 2019-10-08
• Target enrollment: 0
• Participant gender: All

Summary

Background:

Malaria is an illness caused by a parasite that enters people s bodies when a mosquito bites them. It can cause fevers, headaches, body aches, and weakness. If not treated, it can make some people very ill. Malaria can be cured. A mix of 2 drugs that has worked well in the past is not working as well in some parts of Cambodia. Researchers want to see if a mix of 3 drugs works better and is safe.

Objectives:

To see if a 3-drug mix can be used to treat malaria in areas where a 2-drug mix is less effective.

Eligibility:

People aged 2 65 years with mild malaria in Pursat, Preah Vihear, and Ratanakiri Provinces in Cambodia.

Design:

Participants will be screened with medical history, physical exam, urine and blood tests, and an electrocardiogram (ECG). For this, electrodes will be placed on their skin to check their heartbeat.

Participants will spend about 5 nights in the hospital. They will have physical exams and will complete symptom questionnaires daily. They will give blood periodically throughout their stay. For this, a thin plastic tube is placed in an arm vein for the first day, and blood draws using a needle are done after that.

Participants will get either a 2-drug mix or a 3-drug mix for 3 days. They will have 2 ECGs each day of receiving the drugs.

Participants will have follow-up visits once a week over 5 weeks. At these visits, they will have a physical exam and have blood taken. If they have any signs of malaria, they will be re-treated.

The study will last up to 42 days.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Artemisinins; Artenimol; Artesunate; Dihydroartemisinin; Mefloquine; Piperaquine

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)