Impact of Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lampung Province, Sumatra

NCT01389557 | Completed Phase 4

• 2 other identifiers: 45114-245114
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission. The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing, Lampung, Sumatra.

Conditions

Malaria

Keywords

malaria; DHP; PQ; MST

Outcome Measures

Primary Outcomes (1)

• Presence of malaria (P. falciparum and P. vivax) parasites in blood spot

  Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.

  6 months

Interventions

Dihydroartemisinin-piperaquine with primaquine DRUG

P. falciparum : Treated with fixed doses of 40 mg dihydroartemisinin and 320 mg piperaquine based on weight for 3 days (D0, D1 and D2) with max dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets. The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets. P. vivax: DHP (3 days) + primaquine (14 days)

Also known as: DHP, PQ

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All individuals residing Lempasing village, kecamatan Hanura, Lampung province during study period

You may not qualify if:

• Individuals with severe or chronic disease (liver, kidney), infant and pregnant or breastfeeding woman
• Individuals that refuse to sign informed consent are excluded.
• normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
• willingness to sign the informed-consent form

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Inge Sutanto, Hanura Primary Health Center

Lampung, Sumatra, Indonesia

Location

MeSH Terms

Conditions

Malaria

Interventions

Primaquine

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Inge Sutanto, Md PhD

  Univesity of Indonesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DR Inge Sutanto MPHil, Department of Parasitology, Faculty of Medicine

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 8, 2011
• Study Start: February 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 23, 2012

Record last verified: 2011-11

Locations

ID (1)