- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT02089841
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Malaria. (ALE)
Efficacy of Artemether/Lumefantrine for the Treatment of Uncomplicated Plasmodium Falciparum Malaria in Children Five Years After Wide Scale Use of the Drug in Tanzania.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Artemisinin based combination therapies (ACTs) are currently recommended by the World Health Organization (WHO) as first-line treatment for uncomplicated malaria in all malaria endemic countries including Tanzania, that adopted the policy in 2007. ACTs have proven to be highly efficacious in different parts of the world with different malaria endemicity. Artemisinins clear asexual parasites rapidly and they are also potent against P. falciparum gametocytes, hence reducing disease transmission and spread of drug resistance. Nonetheless, a report in Kenya shows an increase in proportion of patients with parasitaemia on day 1. Most recently, resistance against artemisinins has been confirmed in four countries of South-East Asia, and it may spread to Africa.
In order to safeguard ACTs life span, WHO recommends all suspected malaria cases to be confirmed with parasitological diagnosis, followed by prompt treatment with effective antimalarials. It also emphasizes on the need to conduct efficacy studies for the first and second line antimalarial treatments after every two years so as to be able to detect resistance early on its course. Therefore, based on this notion, this study aimed to assess the therapeutic efficacy of Artemether/Lumefantrine among children with uncomplicated falciparum malaria in Bagamoyo district, five years after its wide scale use in Tanzania.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 4
Kontakter och platser
Studieorter
-
-
-
Dar es Salaam, Tanzania, P.O Box 65001
- Muhimbili University of Health and Allied Sciences
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Mono-infection with P. falciparum
- Parasitaemia level of 2000 - 200,000/μL
- Absence of danger signs or signs of severe malaria
- Axillary temperature ≥ 37.5°C or history of fever 24 hours prior to coming to the facility
- Absence of other concomitant infections like pneumonia which can cause fever
- No use of antimalarial drug two weeks prior to the study
- Consent to comply to the protocol.
Exclusion Criteria:
- Presence of general danger signs or signs of severe falciparum malaria
- Severe malnutrition
- Febrile condition due to diseases other than malaria, such as measles, acute lower respiratory infection or other known chronic diseases
- Regular medication which might interfere with antimalarial pharmacokinetics
- History of hypersensitivity reactions or contraindications to any medicine being used in the trial.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Artemether/lumefantrine
In this single-arm study, patients will be treated with Artemether/lumefantrine, and the first, third and fifth doses of the drug will be given under the direct observation of the health workers.
The patients will be followed-up for 42 days, on day 1, 2, 3, 7, 14, 21, 28 and 42 to assess the efficacy of the drug.
|
Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportion of patients without parasitaemia on day 42.
Tidsram: 42 Days
|
Proportion of patients without parasitaemia or with new infection as corrected by molecular genotyping on day 42 will be used to calculate the efficacy of the trial medicine.
|
42 Days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Plasma lumefantrine concentration
Tidsram: 7 days and 14 days
|
Mean plasma lumefantrine concentration among patients on day 7 and day 14 following treatment with artemether/lumefantrine as a predictor of cure rate.
|
7 days and 14 days
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Proportional of patients without parasitaemia on day 42
Tidsram: 42 days
|
Proportion of patients without parasitaemia on day 42 as purely assessed by molecular genotyping of all collected samples on this day, differentiate between recrudescence and new infection and use it to calculate the efficacy of the trial medicine.
|
42 days
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Studierektor: Andreas Martensson, PhD, Karolinska Institutet
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 3.0.2011
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Plasmodium Falciparum Malaria
-
SanofiMedicines for Malaria VentureAvslutadPlasmodium Falciparum-infektionBenin, Burkina Faso, Gabon, Kenya, Uganda
-
SanofiMedicines for Malaria VentureAvslutadPlasmodium Falciparum-infektionBenin, Burkina Faso, Gabon, Kenya, Moçambique, Uganda, Vietnam
-
Syamsudin Abdillah,Ph.D, Pharm DApt. Dian Yudianto; Dr. dr Erni J. Nelwan, Sp.PD, Ph.D; Apt.Hesty Utami...AvslutadOkomplicerad Plasmodium FalciparumIndonesien
-
Novartis PharmaceuticalsRekryteringOkomplicerad Plasmodium Falciparum MalariaElfenbenskusten, Kenya, Ghana, Uganda
-
Medicines for Malaria VentureAvslutadOkomplicerad Plasmodium Falciparum MalariaUganda, Benin, Burkina Faso, Kongo, Demokratiska republiken, Gabon, Moçambique, Vietnam
-
Karolinska University HospitalMuhimbili University of Health and Allied SciencesAvslutadOkomplicerad Plasmodium Falciparum MalariaTanzania
-
University of OxfordRekryteringMalaria | Plasmodium FalciparumStorbritannien
-
University of OxfordEuropean CommissionAvslutadMalaria | Plasmodium FalciparumStorbritannien
-
Centers for Disease Control and PreventionMinistry of Health, LiberiaAvslutadMalaria | Plasmodium Falciparum | Okomplicerad malariaLiberia
-
PfizerAvslutadPLASMODIUM FALCIPARUM MALARIAIndien
Kliniska prövningar på Artemether-lumefantrine
-
University of OxfordMahidol University; Mahidol Oxford Tropical Medicine Research UnitAvslutadFriska | Farmakokinetik | LäkemedelskombinationThailand
-
University of Cape TownLondon School of Hygiene and Tropical MedicineAvslutadHIV | MalariaSydafrika
-
London School of Hygiene and Tropical MedicineRadboud University Medical Center; Centre national de recherche et de formation...Avslutad
-
Novartis PharmaceuticalsMedicines for Malaria VentureAvslutadAkut okomplicerad Falciparum malariaBurkina Faso, Benin, Kongo, Nigeria, Togo
-
University of OxfordMahidol University; Mahidol Oxford Tropical Medicine Research UnitRekryteringFriska | Farmakokinetik | LäkemedelskombinationThailand
-
University of OxfordUniversity of KinshasaAvslutad
-
Dafra PharmaKenya Medical Research InstituteAvslutad
-
Heidelberg UniversityLudwig-Maximilians - University of Munich; Jimma UniversityIndragenVivax malaria
-
University of LiverpoolInfectious Diseases Institute, Makerere University College of Health... och andra samarbetspartnersRekryteringMalaria, FalciparumUganda
-
NovartisAvslutadMalaria | FalciparumBenin, Kenya, Mali, Moçambique, Tanzania