SNPMiner Trials by Shray Alag


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Report for Mutation N86Y

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Parasite Clearance Time and Time to Recurrent Infection Following Treatment With Artemether/Lumefantrine Among Children With Uncomplicated P. Falciparum Malaria Five Years After Wide Scale Use of the Drug in Tanzania

Plasmodium falciparum resistance against artemisinins has been confirmed in South-East Asia and it is expressed phenotypically as a slow rate of parasite clearance. Nonetheless, it is not known whether the problem exist in Tanzania. This study assessed parasite clearance time and time to recurrent infection following treatment with Artemether/Lumefantrine (AL) among children with uncomplicated malaria.

NCT01998295 Instantaneous Clearance Drug: Artemether/lumefantrine
MeSH:Infection

Time to clearance of parasites carrying Pfmdr 1 N86Y and Pfcrt K76T alleles was assessed by molecular genotyping using blood samples collected during the early phase of treatment.. Inclusion Criteria: - Age 6-120 months - Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL - No general danger signs or severe malaria present - Hemoglobin ≥5 g/dL - History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius - No other cause of fever is detectable - No severe malnutrition - Guardian/patient has consented Exclusion Criteria: - general danger signs or signs of severe falciparum malaria - severe malnutrition - febrile condition due to diseases other than malaria - regular medication which might interfere with antimalarial pharmacokinetics - contraindications to any medicine being used Inclusion Criteria: - Age 6-120 months - Presence of asexual P. falciparum parasitaemia of 2000-200 000/μL - No general danger signs or severe malaria present - Hemoglobin ≥5 g/dL - History of fever within 24 hours or axillary temperature ≥ 37.5 degree Celsius - No other cause of fever is detectable - No severe malnutrition - Guardian/patient has consented Exclusion Criteria: - general danger signs or signs of severe falciparum malaria - severe malnutrition - febrile condition due to diseases other than malaria - regular medication which might interfere with antimalarial pharmacokinetics - contraindications to any medicine being used Instantaneous Clearance Infection Artemether/Lumefantrine (AL) has been in wide scale use in Tanzania since 2007 as first line treatment for uncomplicated falciparum malaria. --- N86Y ---

Detailed sampling allowed us to assess parasite clearance, and selection of Plasmodium falciparum multidrug resistance (Pfmdr) 1 N86Y and Plasmodium falciparum chloroquine resistance transporter (Pfcrt) K76T genes between different time points and its association with parasite clearance and recurrence. --- N86Y ---

Primary Outcomes

Description: Time to parasite clearance was assessed by taking blood samples and examining it by light microscopy prior (0 hour) and during treatment at 4, 8, 12 hours and then 6 hourly until two consecutive negative blood slides.

Measure: Time to parasite clearance

Time: 72 hours

Secondary Outcomes

Description: Time taken for parasites to reappear in the peripheral blood of the participant after initial treatment was assessed during the 42 days of follow up from blood samples taken on days 14, 21, 28 and 42.

Measure: Time to recurrent infection

Time: 42 days

Other Outcomes

Description: Blood samples collect on filter papers prior (0 Hour), during and after medication at 4, 8, 12 and after every 6 hours until 72 hours and on day 7 were analyzed by PCR to assess parasite clearance. Parasite positivity after day 7 was considered as recurrent infection.

Measure: Time to parasite clearance

Time: 7 days

Description: Time to clearance of parasites carrying Pfmdr 1 N86Y and Pfcrt K76T alleles was assessed by molecular genotyping using blood samples collected during the early phase of treatment.

Measure: Time to alleles clearance

Time: 168 hours


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