artesunate-amodiaquine (Coarsucam®, Sanofi Aventis, France; 25/50/100 mg artesunate and 67.5/135/270 mg amodiaquine), single daily dose, was administered for three days according to body weight: ≥4.5- < 9 kg (25 mg/67.5 mg), one tablet/dose; ≥9- < 18 kg (50 mg/135 mg), one tablet/dose; ≥18- < 36 kg (100 mg/270 mg), one tablet/dose; ≥36 kg (100 mg/270 mg), two tablets/dose. Artemether-lumefantrine (Coartem®, Novartis Pharma AG, Basel, Switzerland; 20 mg artemether and 120 mg lumefantrine) was administered at zero and eight hours on the first day, and then twice daily for two subsequent days according to body weight: 5-14 kg, one tablet/dose; 15-24 kg, two tablets/dose; 25-34 kg, three tablets/dose; 35 kg and over, four tablets/dose. All drug doses were administered by study nurses at the clinic. At the clinic, children were observed for one hour after each drug administration. Treatments were re-administered if the child vomited within the observation period. Children who vomited the re-administered dose were withdrawn.
Artemether lumefantrine
Manufactured by Novartis
Sourced in Switzerland
Artemether-lumefantrine is a combination of two antimalarial drugs used to treat malaria caused by Plasmodium falciparum. It works by interfering with the growth and development of the malaria parasite.
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Lab products found in correlation
12 protocols using artemether lumefantrine
1
Artesunate-amodiaquine and Artemether-lumefantrine Treatment
2
Comparing Malaria Treatment Regimens
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We assigned eligible participants to repeated therapy with either pyronaridine–artesunate (Shin Poong Pharmaceutical, Ansan, South Korea) or dihydroartemisinin–piperaquine (Alfasigma SpA, Pomezia, [RM], Italy) versus either artemether–lumefantrine (Novartis Pharma AG, Basel, Switzerland) or artesunate–amodiaquine (Sanofi, Paris, France), depending on study centre. There was no direct comparison between pyronaridine–artesunate and dihydroartemisinin–piperaquine. This was an open label study, although microscopists doing the parasitological assessments were masked to treatment allocation. A computer-generated randomisation list for each site within each country was used. To minimise the risk of investigators guessing treatment allocation, when there were two treatments to allocate the block size was randomly two or four and when there were three treatments to allocate the block size was randomly three or six. The University of Bamako data management team enclosed the randomisation code containing the study arm in sealed, opaque, sequentially numbered envelopes. The site investigator opened the envelopes in order and assigned treatment accordingly. Because recruitment criteria for age and bodyweight differed between treatments, a separate randomisation list was generated for each experimental drug.
3
Malaria Diagnosis and Treatment Protocol
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After obtaining the consent of all recruited participants, a RDT was performed. Capillary blood was obtained via finger stick for malaria testing using RDT SD BIOLINE Malaria Ag P.f/Pan test (Abbott, USA). In different visited households, malaria infection was diagnosed only in children ≤ 5 years of age and women aged 15–49 years. Test results were recorded on a patient sheet and data on symptoms were also collected. Participants with positive RDT results were offered immediate treatment with either artemether-lumefantrine for children and pregnant women in their second or third trimester Coartem®, child: 20 mg/120 mg and adult: 80 mg/480 mg (Novartis, Switzerland), or quinine for pregnant women in their first trimester Surquina 250 mg (Innothera Chouzy, France), according to national treatment guidelines.
4
Comparative Efficacy of ACT Regimens
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Enrolled women were randomly allocated to one of the three ACTs using sealed envelopes: dihydroartemisinin-piperaquine (DP), artesunate-mefloquine (ASMQ), or extended regimen artemether-lumefantrine (AL+). DP was given at the standard dose (2.4 mg/kg dihydroartemisinin with 20 mg/kg piperaquine once daily for 3 days), rounded to the nearest half tablet (40 mg/320 mg dihydroartemisinin/piperaquine per tablet manufactured by Holley Pharmacy, China). ASMQ was given at the standard dose (once daily for 3 days) either as loose doses of artesunate (4 mg/kg/day) and mefloquine (8.3 mg/kg/day) or fixed dose (artesunate 200 mg with mefloquine hydrochloride 440 mg each day, manufactured by Far-Manguinhos, Brazil). The loose dose was rounded to the nearest quarter of a tablet for artesunate (50 mg/tablet, Guilin, China) and mefloquine (250 mg/tablet, Atlantic Laboratories Corp., Thailand). AL+ was given as an extended regimen: five tablets (20/120 mg artemether/lumefantrine per tablet, Novartis, Switzerland) twice per day for 4 days (at 0, 8, 24, 36, 48, 60, 72 and 84 h), with 250 mL of chocolate milk containing 7 g of fat for each dose. All doses were fully supervised.
5
Genetically Inferred CYP2D6 Impact on PQ
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Samples from 8 published clinical trials were used for separate analyses on the impact of genetically inferred CYP2D6 metabolizer status on PQ safety and efficacy. For analyses of the impact of CYP2D6 inferred metabolizer status on PQ efficacy, we included samples from 5 PQ efficacy studies. Gametocyte detection was performed following treatment with a single dose of 0.1 to 0.75 mg/kg PQ in combination with either artemether-lumefantrine (AL) (Coartem as a standard 6-dose regimen over 3 days; Novartis Pharma, Switzerland) in Burkina Faso (3 (link)) and Uganda (2 (link)) or dihydroartemisinin-piperaquine (DP) (Eurartesim as a standard 3-day regimen; Sigma-Tau, Italy) in Mali (1 (link)), the Gambia (4 (link)), and Kenya (5 (link)). Analyses on the impact of CYP2D6 inferred metabolizer status on hemolysis were restricted to G6PD-deficient (G6PDd) individuals; we included two additional studies that specifically assessed PQ safety in G6PD-deficient individuals in Mali (20 (link)) and the Gambia (19 (link)), using 0.25 to 0.5 mg/kg PQ in combination with DP. In all studies, hemoglobin (Hb) concentrations in grams per deciliter were measured by a self-calibrating HemoCue photometer (Ängelholm, Sweden). Study details are summarized in Table 1 .
6
Malaria Screening and Treatment Protocol
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A clinical officer was on duty at the research clinic day and night. At recruitment, parents or guardians were requested to bring participating children to the dispensary immediately when detecting fever or any other illness during the intervention period. In samples collected at baseline and from sick children, the presence of parasite-specific lactate dehydrogenase (P. falciparum and other Plasmodium species) was detected by rapid tests (CareStart, G0121, Access Bio, Monmouth Jct, NJ). Axillary temperature was measured using an electronic thermometer and dipstick tests were administered for children with guardian-reported fever; for those with positive test results, plasma samples were collected and measured whole-blood C-reactive protein concentrations using a point-of-care test. Plasma was stored as described for the recruitment procedure. Artemether-lumefantrine (Novartis Pharma, Basel, Switzerland) was administered to any child with current Plasmodium infection upon enrolment, or with reported fever and a positive dipstick test result during the follow-up period.
7
Severe and Uncomplicated Malaria Study
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Patients admitted with asexual stage P. falciparum slide confirmed malaria were enrolled consecutively upon diagnosis. Criteria for severe malaria were: coma (Glasgow Coma Score <11), shock [systolic blood pressure (SBP) <80 mmHg with cool extremities], anaemia, (haematocrit <20% plus parasitaemia >100,000/µl), jaundice (total bilirubin >51.3 μmol/l plus parasitaemia >100,000/µl), hyperparasitaemia (>10%), acidosis (bicarbonate <15 mmol/l), hyperlactataemia (lactate >4 mmol/l), hypoglycaemia (glucose <2.22 mmol/l), convulsions (≥2/24 h), pulmonary oedema, and/or AKI (creatinine >265 μmol/l). Uncomplicated malaria was defined as slide positive malaria without severity criteria. Patients were managed according to WHO treatment guidelines [14 ]. Antimalarial treatment with parenteral artesunate (Guilin No. 2, China) was promptly administered at diagnosis followed by artemether/lumefantrine (Novartis, Switzerland) to complete therapy once oral medication was tolerated. A control group of healthy controls (n = 27) among local hospital staff was also recruited in Chittagong.
8
Primaquine-enhanced Malaria Treatment
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The patients were randomized into control and intervention arms in this open, single-blinded trial. The patients in the control arm received artemether-lumefantrine tablets (20/120 mg) (Coartem®, Novartis Pharma, Switzerland) in accordance with their body weight and the Tanzanian national treatment guidelines for uncomplicated P. falciparum malaria, i.e. twice a day for 3 consecutive days, as follows: one tablet to patients weighing 5–14 kg; two tablets to children weighing 15–24 kg; three tablets to children weighing 25–34 kg and four tablets for patients with a weight above 35 kg. In the intervention arm, patients received artemether-lumefantrine according to the protocol described above for 6 consecutive days. In addition to this, a single dose of 0.25 mg/kg primaquine (Primaquine phosphate, Sanofi) was given together with the last dose of artemether-lumefantrine as supported by modelling data, which suggest that a later primaquine dose has improved gametocidal effect compared to giving with first dose [24 (link)]. ECGs were performed by a qualified physician for both treatment arms, at two time points, i.e. before enrolment and 4–5 h after the 12th (final) dose of artemether-lumefantrine in the extended treatment arm and at the 12th visit (3 days after the last dose) for the control arm.
9
Comparison of Tafenoquine and Artemisinin Combinations
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Study treatments were tafenoquine (150 mg per tablet) (GlaxoSmithKline), dihydroartemisinin-piperaquine tetraphosphate (40 mg/320 mg per tablet) (Eurartesim; Sigma-Tau Industrie Farmaceutiche Riunite SPA), and artemether-lumefantrine (20 mg/120 mg per tablet) (Coartem; Novartis Pharmaceuticals). Subjects were randomized into five cohorts (n = 24 per cohort) to receive tafenoquine on day 1 (300 mg) plus once-daily dihydroartemisinin-piperaquine on days 1, 2, and 3 (120 mg/960 mg for subjects with a body weight of 36 to <75 kg and 160 mg/1,280 mg for subjects with a body weight of ≥75 to 100 kg), or plus artemether-lumefantrine (80 mg/480 mg) with the second dose administered 8 h after the first dose on day 1 and then twice daily on days 2 and 3, or each drug given alone (Fig. 1 ). No dose adjustments were allowed.
10
Gametocyte-positive Malaria Study in Gabon
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The study was conducted at the Centre de Recherches Médicales de Lambaréné (CERMEL), Gabon, from September 2019 to March 2020. Malaria transmission in this hyperendemic area is considered perennial [25 (link)]. Participants in the rural area surrounding Lambaréné were screened for the presence of P. falciparum gametocyte-positive infections. Finger-prick blood was collected and used for the preparation of thick smears from volunteers aged ≥1 year after signed informed consent of participants or caretakers. Asymptomatic and symptomatic participants with microscopic evidence of P. falciparum gametocytes, aged ≥5 years and with a hemoglobin concentration of ≥6 g/dL, were selected as blood donors for the direct membrane feeding assay (DMFA). The following day of the screening, 5 mL of venous blood was collected into a heparinized tube. All participants with confirmed malaria infection were treated either on the following day by the village health workers or following the venous blood collection at the laboratory with artemether-lumefantrine (Coartem, Novartis, Basel, Switzerland) twice daily for 3 days according to manufacturer’s instructions. The protocol of this study was approved by the institutional review board of CERMEL (CEI 013/2019).
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