Efficacy and safety of artemether-lumefantrine (AL) combination therapy for the treatment of uncomplicated Plasmodium falciparum malaria in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand
A study evaluating the efficacy and safety of artemether lumefantrine for the treatment of uncomplicated plasmodium falciparum infections in 4 sites in India Annuppur district, Madhya Pradesh, Jhabua district, Madhya Pradesh, Bastar district, Chhattisgarh and Palamudistrict, Jharkhand
Indian Council of Medical Research, Ministry of Health & Family welfare
352 participants
Jun 10, 2014
Interventional
Conditions
Summary
To study the efficacy of antimalarial drugs in India
Eligibility
Inclusion Criteria1
- Age between 6 months to 60 years ; Mono infection with P. falciparum confirmed by positive blood smear (i.e. no mixed infection), parasitaemia between 1000 and 100000 microliters of asexual forms; measured temperature (depending on method of measurement) or history of fever within previous 24 hours; 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 the absence of severe malnutrition.
Exclusion Criteria1
- Signs and symptoms of severe or complicated malaria according to the definitions of WHO; mixed or mono-infection with another Plasmodium species detected by microscopy; presence of severe malnutrition; febrile conditions due to diseases other than malaria or other know underlying chronic or severe diseases; regular medication which interferes with antimalarial pharmacokinetics; history of hypersensitivity reactions or contraindications to the medicine(s) being tested; positive pregnancy test or breastfeedings; unable to or unwilling to use contraception, including abstinence, for women of child-bearing age and who are sexually active.
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Interventions
Artemether-lumefantrine will be administered according to body weight, twice a day over 3 days, as per WHO recommended dose (WHO guidelines). Tablets containing 20mg base of artemether and 120 mg base of lumefantrine will be administered orally. The number of tablets administered is based on the weight of the patient, twice a day, over three days – 1 tablet for patients of 5-14kg, 2 for patients of 15-24kg, 3 for patients of 25-34kg, 4 over 34kg. All antimalarial drug(s) must be stored in a cool dry environment. All doses of medicine will be administered under the supervision of a qualified member of the staff designated by the principal investigator. The study patients will be observed for 30 min after medicine administration for adverse reactions or vomiting. Any patient who vomits during this observation period will be re-treated with the same dose of medicine and observed for an additional 30 min. If the patient vomits again, he or she will be withdrawn and offered rescue therapy. The therapeutic efficacy study will be carried out in the field clinic and 3-day treatment will be given at field clinic or their home by visiting each day for 3 days as in most malarious places public transport system is not available. Clinical and parasitological parameters will be monitored over a 28-day follow-up period to evaluate drug efficacy
Locations(4)
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ACTRN12614000765628