MalariaPhase 2NCT01614964
Studies of a Candidate Aminoquinoline Antimalarial (AQ-13)
A Phase 2 study testing AQ-13 Treatment and Coartem Treatment in people with Malaria, run by Tulane University at 1 site in Mali.
Trial summary
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. Read more about this study
- Who is it for?
- Ages 18 to 99 years, men only
- Conditions the study is for
- Malaria
- What is being tested?
- AQ-13 Treatment and Coartem Treatment
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteMali
- Study dates
- Aug 2013to Feb 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Malian males ≥ 18 years of age,
- Uncomplicated malaria with ≥ 2,000 asexual P. falciparum parasites per ul, and
- Informed consent obtained and signed.
Who cannot join
- Severe or complicated malaria (including temperature ≥ 40o C),
- ≥ 100,000 asexual parasites per ul of blood,
- Anemia or other laboratory results (other than malaria) that require treatment (e.g., Hb ≤ 7 gm/dL, K+ ≤ 3.5 millimolar (mM), BP ≥ 140/90),
- Seizures or impaired consciousness,
- Recent antimalarial treatment by history (within ≤ 2 weeks),
- Chronic medications (including inducers of Cytochrome P450 3A4 [CYP3A4] activity such as rifampin and nevirapine),
- Ventricular or atrial arrhythmias, or second or third degree heart block on the screening ECG or Holter recording,
- Infection with other plasmodial species on the blood smear (P. ovale, P. ovale, P. vivax).
Trial locations and contacts
1 site in 1 country.
Mali1 site
Clinical Research Center (Hopital Point G, University of the Sciences, Techniques and Technologies of Bamako)
Bamako, BP 1805
About this study
Official title: Phase 2 Proof of Concept Study of a Candidate Aminoquinoline Antimalarial (AQ-13)
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of Orphan Product Development (OOPD).
Read the detailed description
This is an initial efficacy study (Phase 2 Proof of Concept Study) of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.
- Conditions
- Malaria
- Being tested
- AQ-13 Treatment, Coartem Treatment
- Keywords
- Plasmodium falciparum, pharmacokinetics, antimalarials (antimalarial drugs), chloroquine (chloroquine-resistant), QT (QTc) interval
- Medical subject headings
- Malaria, Malaria, Falciparum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AQ-13 TreatmentDrug
Also called N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine.
Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days.
Coartem TreatmentDrug
Also called Tablets contain 20 (or 80) mg artemether and 120 (or 480) mg lumefantrine.
Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coartem tablets over 3 days (each dose containing 80 mg artemether and 480 mg lumefantrine). Those six doses will be given at the time of diagnosis and 8 hours later on day 1, at 24 and 36 hours on day 2 and at 48 and 60 hours on day 3 for total doses of 480 mg artemether and 2880 mg lumefantrine over 3 days.
| Study group | Role | What they receive |
|---|---|---|
| AQ-13 | Experimental | Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days. Receives: Drug: AQ-13 Treatment |
| Coartem Treatment | Active comparator | Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention: Active Comparator: Coartem. Participants randomized to the Coartem arm will be treated with 80 mg artemether and 480 mg lumefantrine at the time of diagnosis and 8 hours later on day 1, the same doses (80 mg artemether and 480 mg lumefantrine) twice on day 2 (24 and 36 hours after diagnosis) and twice more on day 3 (48 and 60 hours after diagnosis) for total oral doses of 480 mg artemether and 2880 mg lumefantrine over 3 days. Receives: Drug: Coartem Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.
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.
Measured: Subjects are followed for 42 days after beginning treatment with either AQ-13 or Coartem..
Secondary outcomes (11)
Number of Participants With Adverse Events
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.
Measured: Within 4 weeks of beginning treatment with either AQ-13 or Coartem
Parasite Clearance Time
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.
Measured: 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.
Number of Participants With Recrudescence of Infection
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.
Measured: Within 42 days after beginning treatment with either AQ-13 or Coartem
QTc Interval Response Following Antimalarial Treatment
Corrected QT (QTc) interval was measured at antimalarial dosing and at 4 hours after dosing using HolterCare (version 10.6.0) monitors.
Measured: Between dosing and 4 hours after dosing
Mean Fever Clearance Time in Days
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.
Measured: Days 1-7 after beginning treatment with either AQ-13 or Coartem
Peak Cmax
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).
Measured: 42 Days
Time to Peak Tmax
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).
Measured: 42 days
1-week AUC
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).
Measured: 42 days
Mean Residence Time
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).
Measured: 42 Days
Clearance
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).
Measured: 42 Days
Elimination t½
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).
Measured: 42 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startAug 2013
- Primary completionJan 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tulane University
- Sponsor type
- University, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako
- Responsible party
- Sponsor
- Investigators
- Donald J. Krogstad, MD, Principal investigator, Tulane School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614964
- Sponsor's protocol ID
- 2149
- Other IDs
- FDA 1R01-FD-003373
- Status last verified
- Jun 2024
- First submitted
- 6 Jun 2012
- Last updated
- 11 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
De D, Krogstad FM, Cogswell FB, Krogstad DJ. Aminoquinolines that circumvent resistance in Plasmodium falciparum in vitro. Am J Trop Med Hyg. 1996 Dec;55(6):579-83. doi: 10.4269/ajtmh.1996.55.579.
PubMed 9025680De D, Krogstad FM, Byers LD, Krogstad DJ. Structure-activity relationships for antiplasmodial activity among 7-substituted 4-aminoquinolines. J Med Chem. 1998 Dec 3;41(25):4918-26. doi: 10.1021/jm980146x.
PubMed 9836608Ramanathan-Girish S, Catz P, Creek MR, Wu B, Thomas D, Krogstad DJ, De D, Mirsalis JC, Green CE. Pharmacokinetics of the antimalarial drug, AQ-13, in rats and cynomolgus macaques. Int J Toxicol. 2004 May-Jun;23(3):179-89. doi: 10.1080/10915810490471352.
PubMed 15204721Deng H, Liu H, Krogstad FM, Krogstad DJ. Sensitive fluorescence HPLC assay for AQ-13, a candidate aminoquinoline antimalarial, that also detects chloroquine and N-dealkylated metabolites. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Apr 3;833(2):122-8. doi: 10.1016/j.jchromb.2005.12.011. Epub 2006 Jan 18.
PubMed 16520100Hocart SJ, Liu H, Deng H, De D, Krogstad FM, Krogstad DJ. 4-aminoquinolines active against chloroquine-resistant Plasmodium falciparum: basis of antiparasite activity and quantitative structure-activity relationship analyses. Antimicrob Agents Chemother. 2011 May;55(5):2233-44. doi: 10.1128/AAC.00675-10. Epub 2011 Mar 7.
PubMed 21383099Mzayek F, Deng H, Mather FJ, Wasilevich EC, Liu H, Hadi CM, Chansolme DH, Murphy HA, Melek BH, Tenaglia AN, Mushatt DM, Dreisbach AW, Lertora JJ, Krogstad DJ. Randomized dose-ranging controlled trial of AQ-13, a candidate antimalarial, and chloroquine in healthy volunteers. PLoS Clin Trials. 2007 Jan 5;2(1):e6. doi: 10.1371/journal.pctr.0020006.
PubMed 17213921Lakshmanan V, Bray PG, Verdier-Pinard D, Johnson DJ, Horrocks P, Muhle RA, Alakpa GE, Hughes RH, Ward SA, Krogstad DJ, Sidhu AB, Fidock DA. A critical role for PfCRT K76T in Plasmodium falciparum verapamil-reversible chloroquine resistance. EMBO J. 2005 Jul 6;24(13):2294-305. doi: 10.1038/sj.emboj.7600681. Epub 2005 Jun 9.
PubMed 15944738Koita OA, Sangare L, Miller HD, Sissako A, Coulibaly M, Thompson TA, Fongoro S, Diarra Y, Ba M, Maiga A, Diallo B, Mushatt DM, Mather FJ, Shaffer JG, Anwar AH, Krogstad DJ. AQ-13, an investigational antimalarial, versus artemether plus lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria: a randomised, phase 2, non-inferiority clinical trial. Lancet Infect Dis. 2017 Dec;17(12):1266-1275. doi: 10.1016/S1473-3099(17)30365-1. Epub 2017 Sep 12.
PubMed 28916443
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Proof of Concept Study of a Candidate Aminoquinoline Antimalarial (AQ-13)
- ClinicalTrials.gov ID
- NCT01614964
- Acronym / sponsor ID
- 2149
- Conditions
- Malaria
- Keywords
- Plasmodium falciparum, pharmacokinetics, antimalarials (antimalarial drugs), chloroquine (chloroquine-resistant), QT (QTc) interval
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Tulane UniversityUniversity, hospital or other
- Collaborators
- University of the Sciences, Techniques and Technologies of Bamako
- Study start
- Aug 2013 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Posted 11 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an initial efficacy study of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 2 doses of Coartem twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites. Funding Source - FDA Office of Orphan Product Development (OOPD).
Detailed description
This is an initial efficacy study (Phase 2 Proof of Concept Study) of a candidate antimalarial in human subjects with uncomplicated malaria caused by the most common and most important parasite in Africa (Plasmodium falciparum). This study will enroll 66 adult Malian males with uncomplicated P. falciparum malaria and randomize them to treatment with 1750 mg of the investigational drug (AQ-13) by mouth over 3 days or the current standard treatment, which is 80 mg of artemether and 480 mg of lumefantrine twice daily for 3 days. The hypothesis underlying this study is that AQ-13 will be similarly effective to Coartem for the treatment of uncomplicated P. falciparum malaria due to both chloroquine-susceptible and chloroquine-resistant parasites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AQ-13 | Experimental | Drug: AQ-13 TreatmentAdult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days. |
| Coartem Treatment | Active comparator | Drug: Coartem TreatmentAdult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention: Active Comparator: Coartem. Participants randomized to the Coartem arm will be treated with 80 mg artemether and 480 mg lumefantrine at the time of diagnosis and 8 hours later on day 1, the same doses (80 mg artemether and 480 mg lumefantrine) twice on day 2 (24 and 36 hours after diagnosis) and twice more on day 3 (48 and 60 hours after diagnosis) for total oral doses of 480 mg artemether and 2880 mg lumefantrine over 3 days. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult Malian males ≥ 18 years of age,
- Uncomplicated malaria with ≥ 2,000 asexual P. falciparum parasites per ul, and
- Informed consent obtained and signed.
Key exclusion criteria (8 listed)
- Severe or complicated malaria (including temperature ≥ 40o C),
- ≥ 100,000 asexual parasites per ul of blood,
- Anemia or other laboratory results (other than malaria) that require treatment (e.g., Hb ≤ 7 gm/dL, K+ ≤ 3.5 millimolar (mM), BP ≥ 140/90),
- Seizures or impaired consciousness,
- Recent antimalarial treatment by history (within ≤ 2 weeks),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AQ-13 TreatmentAlso: N'-(7-Chloroquinolin-4-yl)-N,N-diethyl-propane-1,3-diamine.Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days. | Drug | AQ-13 |
| Coartem TreatmentAlso: Tablets contain 20 (or 80) mg artemether and 120 (or 480) mg lumefantrine.Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coartem tablets over 3 days (each dose containing 80 mg artemether and 480 mg lumefantrine). Those six doses will be given at the time of diagnosis and 8 hours later on day 1, at 24 and 36 hours on day 2 and at 48 and 60 hours on day 3 for total doses of 480 mg artemether and 2880 mg lumefantrine over 3 days. | Drug | Coartem Treatment |
Primary outcome
Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males.
Time frame: 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.
11 secondary outcomes
Number of Participants With Adverse Events
Time frame: Within 4 weeks of beginning treatment with either AQ-13 or Coartem
Parasite Clearance Time
Time frame: 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.
Number of Participants With Recrudescence of Infection
Time frame: Within 42 days after beginning treatment with either AQ-13 or Coartem
QTc Interval Response Following Antimalarial Treatment
Time frame: Between dosing and 4 hours after dosing
Mean Fever Clearance Time in Days
Time frame: Days 1-7 after beginning treatment with either AQ-13 or Coartem
Peak Cmax
Time frame: 42 Days
Time to Peak Tmax
Time frame: 42 days
1-week AUC
Time frame: 42 days
Mean Residence Time
Time frame: 42 Days
Clearance
Time frame: 42 Days
Elimination t½
Time frame: 42 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9025680De D, Krogstad FM, Cogswell FB, Krogstad DJ. Aminoquinolines that circumvent resistance in Plasmodium falciparum in vitro. Am J Trop Med Hyg. 1996 Dec;55(6):579-83. doi: 10.4269/ajtmh.1996.55.579.
- Background: PubMed 9836608De D, Krogstad FM, Byers LD, Krogstad DJ. Structure-activity relationships for antiplasmodial activity among 7-substituted 4-aminoquinolines. J Med Chem. 1998 Dec 3;41(25):4918-26. doi: 10.1021/jm980146x.
- Background: PubMed 15204721Ramanathan-Girish S, Catz P, Creek MR, Wu B, Thomas D, Krogstad DJ, De D, Mirsalis JC, Green CE. Pharmacokinetics of the antimalarial drug, AQ-13, in rats and cynomolgus macaques. Int J Toxicol. 2004 May-Jun;23(3):179-89. doi: 10.1080/10915810490471352.
- Background: PubMed 16520100Deng H, Liu H, Krogstad FM, Krogstad DJ. Sensitive fluorescence HPLC assay for AQ-13, a candidate aminoquinoline antimalarial, that also detects chloroquine and N-dealkylated metabolites. J Chromatogr B Analyt Technol Biomed Life Sci. 2006 Apr 3;833(2):122-8. doi: 10.1016/j.jchromb.2005.12.011. Epub 2006 Jan 18.
- Background: PubMed 21383099Hocart SJ, Liu H, Deng H, De D, Krogstad FM, Krogstad DJ. 4-aminoquinolines active against chloroquine-resistant Plasmodium falciparum: basis of antiparasite activity and quantitative structure-activity relationship analyses. Antimicrob Agents Chemother. 2011 May;55(5):2233-44. doi: 10.1128/AAC.00675-10. Epub 2011 Mar 7.
- Background: PubMed 17213921Mzayek F, Deng H, Mather FJ, Wasilevich EC, Liu H, Hadi CM, Chansolme DH, Murphy HA, Melek BH, Tenaglia AN, Mushatt DM, Dreisbach AW, Lertora JJ, Krogstad DJ. Randomized dose-ranging controlled trial of AQ-13, a candidate antimalarial, and chloroquine in healthy volunteers. PLoS Clin Trials. 2007 Jan 5;2(1):e6. doi: 10.1371/journal.pctr.0020006.
- Background: PubMed 15944738Lakshmanan V, Bray PG, Verdier-Pinard D, Johnson DJ, Horrocks P, Muhle RA, Alakpa GE, Hughes RH, Ward SA, Krogstad DJ, Sidhu AB, Fidock DA. A critical role for PfCRT K76T in Plasmodium falciparum verapamil-reversible chloroquine resistance. EMBO J. 2005 Jul 6;24(13):2294-305. doi: 10.1038/sj.emboj.7600681. Epub 2005 Jun 9.
- Results publication: PubMed 28916443Koita OA, Sangare L, Miller HD, Sissako A, Coulibaly M, Thompson TA, Fongoro S, Diarra Y, Ba M, Maiga A, Diallo B, Mushatt DM, Mather FJ, Shaffer JG, Anwar AH, Krogstad DJ. AQ-13, an investigational antimalarial, versus artemether plus lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria: a randomised, phase 2, non-inferiority clinical trial. Lancet Infect Dis. 2017 Dec;17(12):1266-1275. doi: 10.1016/S1473-3099(17)30365-1. Epub 2017 Sep 12.
- Individual participant dataSharing planned: Undecided
Related trials for Malaria
Active, not recruitingObservational study
Trajectories and Mechanisms of Recovery From Malaria: An Observational Study
Malaria
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
Recruiting
The Effects of Iron Treatment on Vaccine Immunogenicity in Kenyan Infants With Iron Deficiency
Iron Deficiencies
RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
Malaria
RecruitingPhase 1
Safety, Tolerability and Efficacy of PfSPZ-LARC2 Vaccine Against CHMI in Malaria-Naïve Adults
Malaria Falciparum
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald J. Krogstad, MD principal investigator
Tulane School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AQ-13 Treatment and Coartem Treatment in people with Malaria, run by Tulane University at 1 site in Mali.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mali. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure Rates of AQ-13 and Coartem for Uncomplicated Plasmodium Falciparum Malaria in Adult Malian Males. (time frame: Subjects are followed for 42 days after beginning treatment with either AQ-13 or Coartem..). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01614964, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.