Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 12 of 12

List	Outcome	Time frame	Description
Primary	Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.	Subjects are followed for 42 days after beginning treatment with either AQ-13 or Coartem..	Cure rate is defined as a lack of recrudescence within 42 days PCR-corrected (correcting for new infections due to treatment failures). The investigators were looking for no evidence of recurrent infection with the same parasite genotype after reduction of the asexual parasitemia to less than 25% of the admission value by day 3 and clearance of asexual parasites and fever by day 7 to measure the cure rate. Failure is defined as lack of cure.
Secondary	Number of Participants With Adverse Events	Within 4 weeks of beginning treatment with either AQ-13 or Coartem	Adverse events (AEs) are defined as events possibly related to the study drug(s) as judged by blinded physician observers that occur within 4 weeks of beginning treatment with AQ-13 or Coartem. The investigators asked participants to report the less serious adverse events (≤ grade 1) and the grade 2-4 adverse events and counted the number of participants who had those adverse events happen.
Secondary	Parasite Clearance Time	From the time of beginning treatment with either AQ-13 or Coartem to the first of 2 successive negative blood smears, assessed during the 1 week inpatient stay.	Blood smears are performed at the time of diagnosis and then (for persons who have been enrolled after providing their informed consent to participate) twice daily until two successive negative smears have been obtained.
Secondary	Number of Participants With Recrudescence of Infection	Within 42 days after beginning treatment with either AQ-13 or Coartem	Recrudescence of infection with malaria is the reactivation of the disease after treatment due to incomplete eradication of the parasite, Plasmodium. The parasites causing these recurrences had the same molecular markers as the original infections in these participants, they were considered recrudescences (late treatment failures) rather than new infections. The investigators counted the number of participants who had recrudescence of infection.
Secondary	QTc Interval Response Following Antimalarial Treatment	Between dosing and 4 hours after dosing	Corrected QT (QTc) interval was measured at antimalarial dosing and at 4 hours after dosing using HolterCare (version 10.6.0) monitors.
Secondary	Mean Fever Clearance Time in Days	Days 1-7 after beginning treatment with either AQ-13 or Coartem	Body temperature was measured twice daily with an electronic (digital) thermometer during the 5-7 day inpatient stay. Fever clearance time was defined as the first persistently normal temperature (\<37·5°C) during week 1 of inpatient stay.
Secondary	Peak Cmax	42 Days	One of the pharmacokinetic parameters for AQ-13 that was measured was Peak Cmax (Cmax=maximal concentration) which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).
Secondary	Time to Peak Tmax	42 days	One of the pharmacokinetic parameters for AQ-13 that was measured was time to peak tmax (tmax is time from beginning treatment to the maximal concentration), which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).
Secondary	1-week AUC	42 days	One of the pharmacokinetic parameters for AQ-13 that was measured was 1-week area under the curve (AUC) for the first 7 days, which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).
Secondary	Mean Residence Time	42 Days	One of the pharmacokinetic parameters for AQ-13 that was measured was Mean Residence Time (MRT), which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).
Secondary	Clearance	42 Days	One of the pharmacokinetic parameters for AQ-13 that was measured was clearance (Cl/f), which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).
Secondary	Elimination t½	42 Days	One of the pharmacokinetic parameters for AQ-13 that was measured was elimination t½ (t½=elimination half-life) which was calculated based on serial blood levels (35 blood level determinations of AQ-13 and its metabolites over the 42 day study period) and urine collections (24 hour collections for the first four days after beginning treatment).

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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