NCT00158548

Brief Summary

Chloroquine resistant falciparum malaria in Pakistan is prevalent in every malarious area examined. Resistance to the favoured second-line treatment, sulphadoxine-pyrimethamine S/P is rising fast. To avert a repetition of the resistance catastrophe that occurred in SE Asia it is critical to preserve the effective life of SP by using it in combination with artesunate. Efficacy of ACT with artesunate in combination with chloroquine, SP or amodiaquine for treatment of malaria (falciparum or vivax) will be examined in malaria patients in Pakistan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
650

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jun 2001

Typical duration for phase_3

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

September 8, 2005

Last Update Submit

January 11, 2017

Conditions

MalariaFalciparum MalariaVivax Malaria

Keywords

FalciparumVivaxTreatmentAsia

Outcome Measures

Primary Outcomes (3)

  • Day 7 slide clearance rate (complete clearance of trophozoites) assessed by microscopists who are blind to treatment allocation.

  • Day 28 slide clearance rate without subsequent recrudescence.

  • Day 7 gametocyte prevalence.

Secondary Outcomes (9)

  • Day 14 gametocyte prevalence

  • Fever clearance time

  • cure rate (elimination of parasitaemia without recrudescence).

  • Rate and time of parasite clearance.

  • Rate of resolution of fever.

  • +4 more secondary outcomes

Interventions

SP, chloroquine, amodiaquine, primaquine, artesunateDRUG

Eligibility Criteria

Age5 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • adults or children \> 5 yrs
  • weight \> 5 kg
  • monoinfection with P. falciparum or P. vivax
  • history of recent fever
  • consent from patient or parent.

You may not qualify if:

  • patients with signs of severe malaria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HealthNet International

Peshawar, Pakistan

Location

MeSH Terms

Conditions

MalariaMalaria, FalciparumMalaria, Vivax

Interventions

ChloroquineAmodiaquinePrimaquineArtesunate

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

AminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbons

Study Officials

  • Kate Graham, MSc

    HealthNet International, Peshawar, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

June 1, 2001

Study Completion

December 1, 2004

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

PA(1)