NCT01906788

Brief Summary

The investigators' Hypothesis is that "The correct timing of gametocytocidal drug in combination with an effective Artemisinin Combination Therapy can limit the infectiousness of malaria-infected individuals to less than one week after initiation of treatment"

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2013

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

July 20, 2013

Last Update Submit

July 23, 2013

Conditions

Malaria Transmission

Outcome Measures

Primary Outcomes (1)

  • Gametocyte prevalence and density by microscopy and QT-NASBA

    By microscopy and QT-NASBA techniques we will determine and compare gametocyte prevalence and density on day 14 between the Primaquine treatment 2 and 3 arms.

    Day 14

Secondary Outcomes (1)

  • Haemoglobin level

    days 3, 7, 10 and 14

Other Outcomes (1)

  • Proportion of infected mosquitoes

    day 7

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Active comparator: Artemether Lumefantrine 6 dose regime orally

Drug: Artemether Lumefantrine

Group 2

EXPERIMENTAL

Experimental: Artemether Lumefantrine 6 dose regime Plus single dose Primaquine (0.75/kg) on day 0

Drug: Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0

Group 3

EXPERIMENTAL

Experimental: Artemether Lumefantrine 6 dose regimen plus single dose of Primaquine (0.75/kg) on day 2

Drug: Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2

Interventions

Artemether LumefantrineDRUG
Group 1
Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0DRUG
Group 2
Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2DRUG
Group 3

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 3 years - 17 years
  • Residents of research area
  • Willingness to come for complete scheduled follow-up.
  • Uncomplicated malaria with P. falciparum mono-infection
  • Axillary temperature \> 37.5°C and \< 39.5°C, or history of fever in previous 48 hours.
  • No history of adverse reactions to study medication
  • Understanding of the procedures of the study by parent or guardian and willing to participate by signing written informed consent forms

You may not qualify if:

  • Haemoglobin below 9g/dl
  • Inability to take drugs orally
  • Known hypersensitivity to any of the drugs given
  • Reported treatment with antimalarial chemotherapy in the past 2 weeks
  • Evidence of chronic disease or acute infection other than malaria
  • Domicile outside the study area
  • Signs of severe malaria( such as respiratory distress, altered consciousness deep breathing, anaemia)
  • Participating in other malaria studies conducted in the region
  • Mixed malaria parasite species infection
  • Positive pregnant test by Urine (UPT) if participant is female aged above 12 years
  • G6PD deficient using the fluorescence spot test

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bagamoyo Research and Training Centre

Bagamoyo, Tanzania

RECRUITING

Related Publications (1)

  • Shekalaghe S, Mosha D, Hamad A, Mbaga TA, Mihayo M, Bousema T, Drakeley C, Abdulla S. Optimal timing of primaquine to reduce Plasmodium falciparum gametocyte carriage when co-administered with artemether-lumefantrine. Malar J. 2020 Jan 21;19(1):34. doi: 10.1186/s12936-020-3121-3.

    PMID: 31964380DERIVED

MeSH Terms

Interventions

Artemether, Lumefantrine Drug CombinationClinical Protocols

Intervention Hierarchy (Ancestors)

ArtemetherArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSesquiterpenesTerpenesPolycyclic CompoundsDrug CombinationsPharmaceutical PreparationsTherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and Evaluation

Study Officials

  • Seif Shekalaghe, MD, PhD

    Kilimanjaro Clinical Research Institute and Ifakara Health Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Seif Shekalaghe, MD, PhD

CONTACT

+255 755 470472sshekalaghe@ihi.or.tz

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2013

First Posted

July 24, 2013

Study Start

May 1, 2013

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

TA(1)