deltatrials
Completed PHASE4 INTERVENTIONAL 2-arm NCT01392014

Dihydroartemisinin-piperaquine and Primaquine for Uncomplicated Plasmodium Falciparum Cases (DHP+PQ)

Effectiveness of Dihydroartemisinin-piperaquine With or Without Primaquine on Gametocytes Plasmodium Falciparum in Mesoendemic Area of Indonesia

Sponsor: Indonesia University

Conditions Malaria
Updated 7 times since 2017 Last updated: Jul 8, 2011 Started: Dec 31, 2008 Primary completion: Mar 31, 2010 Completion: Oct 31, 2010
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT01392014, this PHASE4 trial focuses on Malaria and remains completed. Sponsored by Indonesia University, it has been updated 7 times since 2008, reflecting limited change activity. This study is part of the global effort to build evidence for infectious disease interventions.

Study Description(click to expand)

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island. The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight. Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection. All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

The study was conducted in Hanura Primary Health Center, Padang Cermin district, Lampung province (105°45'-103°48'E and 3°45'-6°45'S) located at the southern end of Sumatra island.

The study subjects received either 3 day doses of dihydroartemisinin-piperaquine with or without 1 day of primaquine according to their body weight.

Patients with fever or history of fever within the past 24 hours were screened by microscopic examination of Giemsa-stained thick blood films to detect P. falciparum infection.

All subjects were allocated by open-label randomization to receive DHP alone (on Day 0 to Day 2) or DHP plus a single dose of PQ (Day 3). The procedures of drug administration in the study were as follows:

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

7 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE4

  2. Sep 2024 — Present [monthly]

    Completed PHASE4

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE4

  5. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE4

Show 2 earlier versions
  1. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE4

  2. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE4

    First recorded

Dec 2008

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Indonesia University
Data source: Indonesia University

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

Study Locations