Arthemeter-lumefantrine (ART-LUM) is an antimalaria drug manufactured as fixed combination tablets, each containing 20 mg of artemether and 120 mg of lumefantrine. ART-LUM was administrated according to body weight as six consecutive doses: The first dose at diagnosis and the second dose eight hours later, 0- 24-48 hours

Artesunate mefloquine (ASMQ) is an antimalaria drug administered as a combination of artesunate, 4 mg/kg/day, with mefloquine, 8 mg/kg/day orally once a day for 3 days or three times, at an interval of 24 hours (0 h - 24 h - 48 h).

Dihydroartemisinin piperaquine (DHA-PQ ) is an antimalaria drug administered as a combination of dihydroartemisinin, 2.5 mg per kg, with piperaquine phosphate, 20mg per kg daily for 3 days or three times, at an interval of 24 hours

Oral paracetamol is administered at of 50mg/kg body weight per day in three divided doses for fever exceeding 37.5oC.

amoxicillin is an antibiotic administered at 50mg per kg body weight per day for seven days in the event of concomitant bacterial infection, absent on day 0 but present during the follow up.

Quinine is an antimalarial recommended by the WHO and NMCP to be used as second line treatment for malaria. In this study, for cases of treatment failure with the artemisinin based combination therapies, quinine sulphate is administered as a second line or rescue drug at a dose of 25mg base per kg body weight per day in three divided doses for five days. The participant is then classified as ETF or LTF and excluded from the study.

Drug Resistant Malaria Due to Plasmodium Falciparum

Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.

Arthemeter-lumefantrine

Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs

Artesunate mefloquine

Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs

Dihydroartemisinin piperaquine

Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation

Paracetamol

Amoxicillin is an antibiotic with no reported activity on plasmodium

Amoxicillin

quinine sulphate is an antimalaria drug administered as a second line or rescue drug

Quinine

CDC Hospital

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Assessment of Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

The primary endpoint was the 28-day and 42-day cure rates and was defined as proportion of patients with adequate clinical and parasitological response (ACPR) after 28 and 42 days of follow-up. Absence of parasitemia until day 28 and day 42 irrespective of axillary temperature was categorized as an adequate clinical and parasitologic response (ACPR). Secondary endpoints were early treatment failure (ETF), late clinical failure (LCF), late parasitological failure (LPF), adverse events (clinical and laboratory abnormalities), anaemia (Hematocrit < 30%), clearance rate of fever and parasitaemia, and gametocyte

The ability of the drug to restore hemoglobin level back to normal

The ability of the drug to completely eliminate plasmodium in the blood stream including participant without symptoms of fever

blood sample from patients with parasitaemia at any day of follow-up are analysed by PCR to evaluated the genetic profile of the MSP1 and MSP2

University of Bamenda

Ministry of Science and Technology of the People´s Republic of China

National Institute for Parasitic Disease, Chinese Center for Disease Control and Prevention

Tablets 20 mg/120 of Artemether/Lumefantrine will be given to 124 trial patients

Tablets 25mg/67,5 mg of Artesunate/Amodiaquine will be given to 124 trial patients.

Quinine tablet 125mg + Clindamycin syrup 75mg/5ml will be given to 60 children.

Malaria

Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
Weight in kg Number of tablet per dose Age 5 to < 15 kg 1 tablet per dose 15 to < 25 kg 2 tablets per dose 25 to < 35 kg 3 tablets per dose

Artemether/Lumefantrine

Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to < 9kg):1 tablet (25 mg/675mg) for 3 days
1 to 5 years (= 9 kg to < 18 kg)1 tablet(25mg/67,5mg)for 3 days

Artesunate/Amodiaquine

this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow;
Quinine:
9 to < 11 kg: ½ tablets 12 to < 19 kg: 1 tablets per dose 20 to < 27 kg: 1½ tablets per dose 28 to < 35 kg: 2 tablets per dose
Clindamycin syrup:
10 mg/kg twice daily

Quinine + Clindamycin

Centre de Santé Lisungi

Kazo Health centre IV

Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

A Randomized Clinical Trial to Measure the Impact of Retreatment With an Artemisinin-based Combination on Malaria Incidence and Its Potential Selection of Resistant Strains

Parasitaemia after day 3 in the absence of fever (axillary temperature <37.5°C)

Proportion of children without (PCR not adjusted) treatment failure (TF28U): all treatment failures detected during the active follow up, regardless of genotyping.

All clinical treatment failures detected during the 42 days follow up for the first line treatment, with and without PCR adjustment. As no active monitoring of parasitaemia after day 3 is planned this includes ETF and LCF following WHO criteria.

The time (in days) from the time of randomization to the first two consecutive measurements on 2 different days of axillary temperature below 37.5°C.

Asexual parasite clearance time is defined as the time (in days) from time of randomization to 2 consecutive negative blood slides (collected at different days). The time to the event will be taken as the time to the first negative slide.
5. Gametocytaemia (prevalence and density) at day 7, 14, 21 and 28 after treatment.

Variation in Hb level between two measurements.

Development of danger signs or severe malaria on Day 0, Day 1 Day 2 or Day 3, in the presence of parasitaemia Parasite density on Day 2 > Day 0 count, irrespective of axillary temperature Presence of parasitaemia on Day 3 with fever (axillary temperature ≥ 37.5°C) Parasitaemia on Day 3 ≥ 25 % of count on Day 0.

Development of danger signs or severe malaria after Day 3 in the presence of parasitaemia Presence of parasitaemia and fever on any day from Day 4 to Day 28

Jean-Pierre Van geertruyden

Prof

Universiteit Antwerpen

European and Developing Countries Clinical Trials Partnership (EDCTP)

Fund for Scientific Research, Flanders, Belgium

Institute of Tropical Medicine, Belgium

University of Kinshasa

Centre Muraz

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Makerere University

once every month during september, October and November

SP, amodiaquine, piperaquine, dihdroartemisinin

SP(500mg sulfadoxine/25mg pyrimethamine)1.25mg SP per kg stat Amodiaquine (200mg base) 25mg/kg over 3 days Piperaquine (320 mg per tablet) 16.8 g/kg daily for 3 days Du-Cotecxin ( 40mg dihydroartemisinin(DHA)/320mg piperaquine(PQP))PQP/DHA 1.6/12.8mg/kg once daily for 3 days

intermittent preventive treatment

Du-Cotecxin (40mg dihydroartemisinin (DHA/320mg Piperaquine (PQP) PQP/DHA 1.6/12.8mg/kg once daily for 3 days

Du-Cotecxin

Medical Research Council Laboratories,

Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

Comparison of Safety, Tolerability and Efficacy of Three Drug Combinations for Intermittent Preventive Treatment in Children Aged 1-5 Years in an Area of Seasonal Malaria Transmission in Upper River Division, The Gambia

artemether/pykinimas

Antimalaria Drugs Susceptibility Testing for an Effective Management of Infected Patients in Sub-Sahara Africa

Impact of Artemisinin-based Combination Therapy and Quinine on Treatment Failure and Resistance in Uncomplicated Malaria

Comparison of Three Drug Combinations for Intermittent Treatment of Malaria in Children

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