Trial · NCT01614964

Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)

NCT01614964, Phase 2, Completed, Tulane University; results first posted 2024-07-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Studies of a Candidate Aminoquinoline Antimalarial (AQ-13). Trials, record NCT01614964. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01614964

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)
NCT number: NCT01614964
Status: Completed
Phases: Phase 2
Enrollment: 66 participants, actual
Lead sponsor: Tulane University
Conditions: Malaria
Interventions: AQ-13 Treatment, Coartem Treatment
First posted: 2012-06-08
Last updated: 2024-07-11
Results first posted: 2024-07-11
Limitations and caveats: The Principal Investigator, Dr. Donald Krogstad, died on August 14, 2020 (see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7543845/). The Results Point of Contact has been updated to list Jeffrey G. Shaffer, PhD.

Source ClinicalTrials.gov

Registered outcomes12

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

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).

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

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

Type	Outcome	Time frame	Population	Units	Measured as
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..		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Adverse Events	Within 4 weeks of beginning treatment with either AQ-13 or Coartem		Participants	COUNT_OF_PARTICIPANTS
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.		Hour	MEAN
SECONDARY	Number of Participants With Recrudescence of Infection	Within 42 days after beginning treatment with either AQ-13 or Coartem	Two participants who withdrew on day 4 and three who were lost to follow-up were not included in this analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	QTc Interval Response Following Antimalarial Treatment	Between dosing and 4 hours after dosing		ms	MEAN
SECONDARY	Mean Fever Clearance Time in Days	Days 1-7 after beginning treatment with either AQ-13 or Coartem		Days	MEAN
SECONDARY	Peak Cmax	42 Days		μM	MEAN
SECONDARY	Time to Peak Tmax	42 days		Hours	MEAN
SECONDARY	1-week AUC	42 days		μM/h	MEAN
SECONDARY	Mean Residence Time	42 Days		Days	MEAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.	AQ-13		28		Participants
Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.	Coartem Treatment		31		Participants
Number of Participants With Adverse Events	AQ-13	Less serious adverse events (≤ grade 1)	32		Participants
Number of Participants With Adverse Events	Coartem Treatment	Less serious adverse events (≤ grade 1)	33		Participants
Number of Participants With Adverse Events	AQ-13	Grade 2-4 adverse events	0		Participants
Number of Participants With Adverse Events	Coartem Treatment	Grade 2-4 adverse events	0		Participants
Parasite Clearance Time	AQ-13		47.3	95% Confidence Interval 43.5 to 51.1	Hour
Parasite Clearance Time	Coartem Treatment		32.5	95% Confidence Interval 28.0 to 37.0	Hour
Number of Participants With Recrudescence of Infection	AQ-13		0		Participants
Number of Participants With Recrudescence of Infection	Coartem Treatment		2		Participants

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	AQ-13	33
Overall Study	STARTED	Coartem Treatment	33
Overall Study	COMPLETED	AQ-13	28
Overall Study	COMPLETED	Coartem Treatment	33
Overall Study	NOT COMPLETED	AQ-13	5
Overall Study	NOT COMPLETED	Coartem Treatment	0

Source ClinicalTrials.gov

Adverse events32

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fever	Infections and infestations	AQ-13	32	33
other	Fever	Infections and infestations	Coartem Treatment	29	33
other	Weakness	Musculoskeletal and connective tissue disorders	AQ-13	27	33
other	Weakness	Musculoskeletal and connective tissue disorders	Coartem Treatment	28	33
other	Myalgias and arthralgias	Musculoskeletal and connective tissue disorders	AQ-13	27	33
other	Myalgias and arthralgias	Musculoskeletal and connective tissue disorders	Coartem Treatment	25	33
other	Headache	Nervous system disorders	AQ-13	32	33
other	Headache	Nervous system disorders	Coartem Treatment	31	33
other	Anorexia	Gastrointestinal disorders	AQ-13	24	33
other	Anorexia	Gastrointestinal disorders	Coartem Treatment	20	33

1 to 10 of 32Source ClinicalTrials.gov

See all 32 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	AQ-13	0	33
Total, all-cause mortality	Coartem Treatment	0	33
Total, other adverse events	AQ-13	32	33
Total, other adverse events	Coartem Treatment	33	33
Total, serious adverse events	AQ-13	0	33
Total, serious adverse events	Coartem Treatment	0	33

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
9025680	BACKGROUND	PubMed
9836608	BACKGROUND	PubMed
15204721	BACKGROUND	PubMed
15944738	BACKGROUND	PubMed
16520100	BACKGROUND	PubMed
17213921	BACKGROUND	PubMed
21383099	BACKGROUND	PubMed
28916443	RESULT	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
AQ-13 vs Coartem Treatment: Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.	Trial comparisons
AQ-13 vs Coartem Treatment: Number of Participants With Recrudescence of Infection	Trial comparisons
AQ-13 vs Coartem Treatment: deaths from any cause	Trial comparisons
AQ-13 vs Coartem Treatment: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01614964

GET https://conductscience.org/api/trials/v1/NCT01614964/events?page=2

API reference For AI assistants