Efficacy, Safety, and Tolerability of Dihydroartemisinin-piperaquine + Mefloquine Compared to Dih… (NCT02612545) | Clinical Trial Compass
CompletedPhase 1
Efficacy, Safety, and Tolerability of Dihydroartemisinin-piperaquine + Mefloquine Compared to Dihydroartemisinin-piperaquine or Artesunate-mefloquine in Patients With Uncomplicated Falciparum Malaria in Cambodia
Cambodia216 participantsStarted 2015-11-20
Plain-language 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.
Who can participate
Age range
2 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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...
Timeframe: Day 42 post enrollment
Trial details
NCT IDNCT02612545
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)