NCT01775592

Brief Summary

Resistance of Plasmodium falciparum toward Artemisinins, the most important drug for the successful treatment of malaria, has been confirmed in Cambodia. There are few reports from neighbouring countries about delayed parasite rates. The investigators therefore aim to assess parasite clearance in malaria patients in central Vietnam when treated according to national standard guidelines.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 11, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

4 months

First QC Date

January 11, 2013

Last Update Submit

January 25, 2013

Conditions

Plasmodium Falciparum

Keywords

P.f resistance

Outcome Measures

Primary Outcomes (1)

  • Parasite clearance time

    Day 2-5

Secondary Outcomes (2)

  • efficacy of DHA-PPQ at day 42 post-treatment in Traleng Quangnam, Vietnam

    Day 42

  • in vitro susceptibility of P.falciparum isolates towards DHA and PPQ in Quang Nam Province

    Day 3-10

Other Outcomes (1)

  • genetic profiles of P.falciparum isolates with delayed and those with normal clearance times in order to identify potential markers of resistance

    1year

Study Arms (1)

Arterakin

OTHER

Number of DHA- PPQ (Arterakin™) tablets per day at 0hour, 8hours, 24hours, 48hours (according to age): 2 - 3 years:0.5, 0.5, 0.5, 0.5 3 - \< 8 years: 1.0, 1.0, 1.0, 1.0 8 - \< 15 years:1.5, 1.5, 1.5, 1.5 ≥ 15 years:2.0, 2.0, 2.0, 2.0

Drug: Arterakin (DHA-PPQ)

Interventions

Arterakin (DHA-PPQ)DRUG
Arterakin

Eligibility Criteria

Age2 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Age: from 6 months of age;
  • Fever (body temperature above 37.5C) or history of fever in the previous 24 hours;
  • Mono-infection with P.falciparum with parasite density between 500-100,000/µl
  • Written informed consent to participate to the trial. For patients aged less than 18 years, an informed consent will be obtained from a parent or a guardian.

You may not qualify if:

  • Mixed malaria infection;
  • Pregnancy or lactation (urine test for β human chorionic gonadotropin to be performed on any woman of child bearing age unless menstruating);
  • Concomitant acute illness necessitating specific treatment (antibiotics);
  • Underlying chronic severe illness (e.g. cardiac, renal, hepatic diseases, HIV/AIDS).
  • Severe malnutrition;
  • Danger signs:
  • not able to drink
  • incontrollable vomiting
  • recent history of convulsions (\>1 in 24 hours)
  • unconscious state; neurological impairment
  • unable to sit or stand
  • Signs of severe malaria:
  • Cerebral malaria (unrousable coma)
  • Severe anaemia (Htc\< 15%)
  • Renal failure (serum creatinine \> 3 mg/dL)
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Centre Tra Leng

Tra Leng, Quang Nam, Vietnam

Location

Related Publications (1)

  • Thriemer K, Hong NV, Rosanas-Urgell A, Phuc BQ, Ha do M, Pockele E, Guetens P, Van NV, Duong TT, Amambua-Ngwa A, D'Alessandro U, Erhart A. Delayed parasite clearance after treatment with dihydroartemisinin-piperaquine in Plasmodium falciparum malaria patients in central Vietnam. Antimicrob Agents Chemother. 2014 Dec;58(12):7049-55. doi: 10.1128/AAC.02746-14. Epub 2014 Sep 15.

    PMID: 25224002DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Annette Erhart, MD, PhD

    ITM

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2013

First Posted

January 25, 2013

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

VN(1)