deltatrials
Suspended PHASE3 INTERVENTIONAL NCT00442403

Safety and Efficacy of Chloroquine Associated With Dehydroepiandrosterone Sulphate to Treat Uncomplicated Falciparum Malaria

Etude de l'Activite (Efficacite et Tolerance) de l'Association de la Chloroquine Avec la Dehydroepiandrosterone-Sulfate (Dheas) Dans le Traitement de l'Acces Palustre Simple A Plasmodium Falciparum

Sponsor: Université Victor Segalen Bordeaux 2

Conditions Malaria
Updated 10 times since 2017 Last updated: Feb 28, 2007 Started: Apr 30, 2002 Completion: Sep 30, 2002
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Suspended

At the end of the year 2002, Cameroon switched from chloroquine to amodiaquine as first-line therapy for of uncomplicated malaria.

Listed as NCT00442403, this PHASE3 trial focuses on Malaria and remains suspended. Sponsored by Université Victor Segalen Bordeaux 2, it has been updated 10 times since 2002, reflecting substantial change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For some strains of P. falciparum and P. berghei, the resistance to CQ and AQ is linked to an increase in reduced glutathione (GSH) levels and GSH-related enzyme activity, such as glucose 6-phosphate deshydrogenase (G6PD). The pro-hormone dehydroepiandrosterone sulphate can be used to potentiate the antimalarial action of CQ on drug resistant P. falciparum strains, by inhibiting parasite G6PD activity. This hormone has a second advantage: it is metabolised in human into a series of potent immunomodulatory steroids which may be in the causal pathway that allowed the induction of protective immune responses against several infections, included malaria. This first study evaluated the tolerance and efficacy of a standard CQ regimen supplemented with dehydroepiandrosterone sulphate for the treatment of drug resistant uncomplicated falciparum malaria.

Worldwide progression of Plasmodium falciparum chloroquine (CQ), amodiaquine and sulfadoxine-pyrimethamine resistance leaves few alternative for the control of malaria, particularly in Africa. For some strains of P. falciparum and P. berghei, the resistance to CQ and AQ is linked to an increase in reduced glutathione (GSH) levels and GSH-related enzyme activity, such as glucose 6-phosphate deshydrogenase (G6PD). The pro-hormone dehydroepiandrosterone sulphate can be used to potentiate the antimalarial action of CQ on drug resistant P. falciparum strains, by inhibiting parasite G6PD activity. This hormone has a second advantage: it is metabolised in human into a series of potent immunomodulatory steroids which may be in the causal pathway that allowed the induction of protective immune responses against several infections, included malaria. This first study evaluated the tolerance and efficacy of a standard CQ regimen supplemented with dehydroepiandrosterone sulphate for the treatment of drug resistant uncomplicated falciparum malaria.

Status Flow

~Jan 2017 – ~Aug 2017 · 7 months · monthly snapshotSuspended~Aug 2017 – ~May 2018 · 9 months · monthly snapshotSuspended~May 2018 – ~Sep 2020 · 28 months · monthly snapshotSuspended~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshotSuspended~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshotSuspended~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotSuspended~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotSuspended~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotSuspended~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotSuspended~Sep 2025 – present · 7 months · monthly snapshotSuspended

Change History

10 versions recorded
  1. Sep 2025 — Present [monthly]

    Suspended PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Suspended PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Suspended PHASE3

  4. Dec 2021 — Jul 2024 [monthly]

    Suspended PHASE3

  5. Jan 2021 — Dec 2021 [monthly]

    Suspended PHASE3

Show 5 earlier versions
  1. Nov 2020 — Jan 2021 [monthly]

    Suspended PHASE3

  2. Sep 2020 — Nov 2020 [monthly]

    Suspended PHASE3

  3. May 2018 — Sep 2020 [monthly]

    Suspended PHASE3

  4. Aug 2017 — May 2018 [monthly]

    Suspended PHASE3

  5. Jan 2017 — Aug 2017 [monthly]

    Suspended PHASE3

    First recorded

Apr 2002

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Université Victor Segalen Bordeaux 2
Data source: Université Victor Segalen Bordeaux 2

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations