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Trial · NCT03355664

Outcomes28

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYPolymerase Chain Reaction Corrected Efficacy Defined as Adequate Clinical and Parasitological Response (ACPR) by Study Arm42 daysParticipantsCOUNT_OF_PARTICIPANTS
SECONDARY42-day Polymerase Chain Reaction Corrected Efficacy According to Site/Geographic Region42 dayThe numbers analysed differ from the overall total as for this secondary analysis we report efficacy stratified by each of the 3 study sites.ParticipantsCOUNT_OF_PARTICIPANTS
SECONDARYParasite Clearance Half-life42 dayHoursMEAN
SECONDARYFever Clearance Time42 dayHours to fever clearanceMEAN
SECONDARYNumber of Severe Adverse Events by Study Arm42 daysParticipantsNUMBER
SECONDARYIncidence of Adverse Events Concerning Markers of Hepatic or Renal Toxicity42 dayEventsNUMBER
SECONDARYIncidence of Prolongation of the Corrected QT Interval28 dayEventsNUMBER
SECONDARYProlongation of the Corrected QT IntervalHour 4, Hour 24, Hour 28, Hour 48, Hour 52, Hour 60, Hour 64, Day 7 and Day 28 and between these time pointsEventsNUMBER
SECONDARYParasite Reduction Rates24 and 48 hours
SECONDARYParasite Count to Fall 50%42 days
SECONDARYParasite Count to Fall 90%42 days
SECONDARYParasite Count to Fall 99%42 days
SECONDARYChange in HaematocritDay 1 to 7, 14, 21, 28, 35, 42
SECONDARYCorrelation Between the Host Genotype and the Pharmacokinetics and Pharmacodynamics of Antimalarials42 day
SECONDARYProportion of Patients That Reports Completing a Full Course of Observed TACT or ACT42 day
SECONDARYPrevalence of Kelch13 Mutations of Known Significance42 day
SECONDARYPrevalence/Incidence of Other Genetic Markers of Antimalarial Drug Resistance Such as Multidrug Resistance Gene 1 Copy Number and Multidrug Resistance Gene 1 Mutations48 hours
SECONDARYGenome Wide Association With in Vivo/in Vitro Sensitivity Parasite Phenotype42 day
SECONDARYCorrelation Between Single Nucleotide Polymorphisms and Whole Genome Sequencing42 day
SECONDARYA Comparison of Transcriptomic Patterns Between Sensitive and Resistant Parasitesbaseline and t = 6 hours

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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