NCT00440752

Brief Summary

The newly introduced antimalarial drug artemether-lumefantrine is currently recommended as second line antimalarial in Sudan. Recurrent infection after treatment with this drug has been associated with selection of certain genes in the malaria parasite. However there is no information on this association in Sudan.This study is going to look into the genetics of resistance to artemether-lumefantrine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2006

Shorter than P25 for all trials

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

October 1, 2006

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 27, 2007

Completed
Last Updated

March 26, 2008

Status Verified

October 1, 2007

First QC Date

February 26, 2007

Last Update Submit

March 25, 2008

Conditions

Falciparum MalariaAntimalarials

Keywords

Artemether-lumefantrinePlasmodium falciparumdrug resistance genes

Outcome Measures

Primary Outcomes (1)

  • Levels of expression of pfcrt and pfmdr-1 alleles on day 0, 3, 7, 14, 21, 28 detected by real-time PCR.

    2007 to 2009

Secondary Outcomes (2)

  • Parasitological failure occurring at day 3, 7, 14, 21, 28 or any other day during this period.

    within 28 days of subject recruitment

  • Gametocyte development detected by reverse transcriptase PCR on day 0, 3, 14 and 28

    2008 to 2009

Study Arms (1)

AL

Cohort of study participants receiving treatment with artemether-lumefantrine

Eligibility Criteria

Age2 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample

You may qualify if:

  • Mono-infection with P. falciparum by microscopy.
  • Initial parasite density of 1000 to 100,000 asexual parasites/µl.
  • Absence of general danger signs or other signs of severe and complicated falciparum malaria according to WHO definitions.
  • Informed consent provided by patient or parent/guardian.

You may not qualify if:

  • Pregnancy
  • Infection with mixed Plasmodium sp.
  • Signs of severe malaria or any danger signs
  • Refusal to provide consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tropical Medicine Research Institute

Khartoum, Khartoum State, 11111, Sudan

Location

Related Publications (3)

  • Dokomajilar C, Nsobya SL, Greenhouse B, Rosenthal PJ, Dorsey G. Selection of Plasmodium falciparum pfmdr1 alleles following therapy with artemether-lumefantrine in an area of Uganda where malaria is highly endemic. Antimicrob Agents Chemother. 2006 May;50(5):1893-5. doi: 10.1128/AAC.50.5.1893-1895.2006.

    PMID: 16641472BACKGROUND

  • Humphreys GS, Merinopoulos I, Ahmed J, Whitty CJ, Mutabingwa TK, Sutherland CJ, Hallett RL. Amodiaquine and artemether-lumefantrine select distinct alleles of the Plasmodium falciparum mdr1 gene in Tanzanian children treated for uncomplicated malaria. Antimicrob Agents Chemother. 2007 Mar;51(3):991-7. doi: 10.1128/AAC.00875-06. Epub 2006 Dec 28.

    PMID: 17194834BACKGROUND

  • Sisowath C, Stromberg J, Martensson A, Msellem M, Obondo C, Bjorkman A, Gil JP. In vivo selection of Plasmodium falciparum pfmdr1 86N coding alleles by artemether-lumefantrine (Coartem). J Infect Dis. 2005 Mar 15;191(6):1014-7. doi: 10.1086/427997. Epub 2005 Feb 8.

    PMID: 15717281BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood spots on glass fibre membranes. 0.5ml of whole blood preserved in TRI reagent.

MeSH Terms

Conditions

Malaria, Falciparum

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Colin Sutherland, PhD.

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Badria B El-Sayed, PhD

    Tropical Medicine Research Institute

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 26, 2007

First Posted

February 27, 2007

Study Start

October 1, 2006

Study Completion

December 1, 2006

Last Updated

March 26, 2008

Record last verified: 2007-10

Locations

SU(1)