Efficacy and safety of artesunate-mefloquine for the treatment of uncomplicated Plasmodium falciparum malaria in Binh Phuoc and Dak Nong provinces, Viet Nam, in 2019.
- Conditions
- Patients infected Plasmodium falciparum malaria.Infection - Other infectious diseases
- Registration Number
- ACTRN12620001375943
- Lead Sponsor
- World Health Organization
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- All
- Target Recruitment
- 84
•age between 02 to 60 ages;
•mono-infection with P. falciparum detected by microscopy;
•parasitaemia from 500 to 100,000/µl asexual forms;
•presence of axillary temperature greater than or equal to 37.5 °C or history of fever during the past 24 h;
•ability to swallow oral medication;
•ability and willingness to comply with the study protocol for the duration of the study and to comply with the study visit schedule; and
•informed consent from the patient or from a parent or guardian in the case of children.
•informed assent from any minor participant aged from 12 to 18 years; and
•consent for pregnancy testing from female of child-bearing age (defined as age over 12 years and sexually active) and from their parent or guardian if under the age of majority years (18 years old).
•presence of general danger signs in children aged under 5 years or signs of severe falciparum malaria according to the definitions of WHO
•weight under 5 kg;
•mixed or mono-infection with another Plasmodium species detected by microscopy;
•presence of severe malnutrition defined as a child aged 6-60 months whose weight-for-high is below –3 z-score, has symmetrical oedema involving at least the feet or has a mid-upper arm circumference < 115 mm);
•presence of febrile conditions due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhea with dehydration) or other known underlying chronic or severe diseases (e.g. cardiac, renal and hepatic diseases, HIV/AIDS);
•regular medication, which may interfere with antimalarial pharmacokinetics;
•history of hypersensitivity reactions or contraindications to any of the medicine(s) being tested or used as alternative treatment(s);
•a positive pregnancy test or breastfeeding; and
•unable to or unwilling to take pregnancy test or to use contraception for women of child-bearing age and who are sexually active.
•history of hypersensitivity reactions or contraindications to the medicine(s) being tested; and
•Unmarried female age 12 – 18 years old.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The proportion of patient with an adequate clinical and parasitological response without and with PCR correction as indicators of treatment efficacy. <br>Clinical response and adequate parasite is upon: After 42 days of treatment with Artesunate-mefloquin since the first dose, the patient did not reappear plasmodium falciparum parasite in the blood and there was no fever[Evaluate weekly for 42 days after dose.<br>Patients are monitored clinically and blood parasites from day 0, day 1, day 2, day 3, day 7, day 14, day 21, day 28, day 35 and day 42 from the start of taking the drug .];To evaluate the frequency and nature of adverse events after dose by questionnaire, obsevation, clinical examination, participant self-reported [Assess afer doses at D1, D2, D3, D7, D14, D21 and D28 ]
- Secondary Outcome Measures
Name Time Method The numbers of patients is the positive malaria slide at 72 hours after treatment initiation[Assess every 12 hours for 72 hours after dose by taken blood slides then stain with giemsa and exam by microscopy ( microccopic blood examination) to detect malaria parasites];To determine the Parasite clearance time by microscopic blood examination.[Every 12 hours to negative slides.];To determine the fever clearance time by themometer with axillary temparute[Every 12 hours up to fall below 37.5 0C and remain there for at least 24 hours ];Kaplan Meier analysis over 42 days for recrudescences and reinfections.<br>To evaluate relapse or re-infection we use blood drops on absorbent paper as PCR technique to determine.[Assess weekly for 42 days after doses]