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Report for Clinical Trial NCT02909712

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Cardiac Safety of Dihydroartemisinin-Piperaquine Amongst Pregnant Women in Tanzania

Sulfadoxine-pyrimethamine (SP) is currently recommended by the World Health Organization for use as intermittent preventive treatment against malaria in pregnancy (IPTp) in areas of moderate to high malaria transmission. However, in some locales malaria parasites have lost sensitivity to SP, compromising its protective effect. Dihydroartemisinin-piperaquine (DP) is a candidate replacement for SP. This trial is designed to confirm the cardio-safety of DP compared to SP amongst pregnant women in Tanzania.

NCT02909712 Malaria Pregnancy Malaria Cardiotoxicity Cardiac Safety Parasitemia
MeSH:Malaria Parasitemia Cardiotoxicity

2 Interventions

Name: sulfadoxine-pyrimethamine (SP)

Description: Women in Groups 1 and 2 will be provided the following SP regimen as directly observed therapy: 3 tablets total of 500 mg sulphadoxine and 25 mg pyrimethamine; 1 day of dosing.
Type: Drug
Group Labels: 1

sulfadoxine-pyrimethamine (SP)

Name: dihydroartemisinin-piperaquine (DHA-PQP)

Description: Women in Groups 3 and 4 will be provided the following DHA-PQP regimen as directly observed therapy 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine daily; 9 tablets total; 3 days of dosing.
Type: Drug
Group Labels: 1

dihydroartemisinin-piperaquine (DHA-PQP)


Primary Outcomes

Measure: Mean QTcF/QTcB change from baseline and proportion of pregnant women treated with DHA-PQP who experienced changes in RR, HR, PR, QRS, QT, QTcF and QTcB measurements from Day 0 pre-dose to Day 2 post-dose.

Time: Measured on day 2 post-dose

Measure: Mean QTcF/QTcB change from baseline and proportion of pregnant women treated with DHA-PQP who experience changes in QT, QTcF and QTcB measurements from Day 0 pre-dose to Day 7.

Time: Measured on day 7 post-dose

Secondary Outcomes

Description: Clinical assessment

Measure: Proportion of pregnant women treated with DHA-PQP/SP with and without asymptomatic parasitaemia who experienced clinical symptoms that could be related with a cardiac arrhythmia.

Time: Measured on day 28 post-dose

Description: Electrocardiography

Measure: Mean QTcF/QTcB change from baseline and proportion of pregnant women treated with SP who experience changes in QT, QTcF and QTcB measurements from Day 0 pre-dose to Day 7

Time: Measured on day 7 post-dose

Description: Electrocardiography

Measure: Comparative analysis of the QT changes from Day 0 pre-dose to Day 7 post first dosing in pregnant women given DHA-PQP versus SP

Time: Measured on day 7 post-dose

Description: Electrocardiography

Measure: Analysis of values and changes from baseline for the other electrocardiogram (ECG) parameters (RR, HR, PR, QRS) in pregnant women given DHA-PQP or SP

Time: Measured on day 7 post-dose

Description: Efficacy

Measure: Adequate Parasitological Responses (APR) at Days 7, 14, 21 and 28 post-dose, PCR-Corrected and uncorrected

Time: Measured on day 28 post-dose

Description: Parasite resistance

Measure: Proportion of participants in Groups 1-4 with parasites at Days 0, 7, 14, 21 and 28 that carry the 581G and/or K540E mutations associated with SP resistance

Time: Measured on days 28 post-dose

Purpose: Basic Science

Allocation: Randomized

Parallel Assignment


There are 2 SNPs

SNPs


1 A581G

Polymerase chain reaction (PCR) methods will be used for genetic sequencing of molecular markers (A581G) associated with malaria parasite drug resistance to SP. --- A581G ---


2 K540E

Proportion of participants in Groups 1-4 with parasites at Days 0, 7, 14, 21 and 28 that carry the 581G and/or K540E mutations associated with SP resistance. --- K540E ---



HPO Nodes