NCT00374205

Brief Summary

The purpose of this study is to compare the effectiveness and safety of two Artemisinin Combination Therapies (ACTs) for the treatment of children with uncomplicated Plasmodium falciparum malaria

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
245

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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, 2006

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

November 27, 2007

Status Verified

November 1, 2007

First QC Date

September 8, 2006

Last Update Submit

November 26, 2007

Conditions

Malaria, Falciparum

Keywords

GhanaEffectivenessSafetyDrug-ResistanceACTCoartemArsucam

Outcome Measures

Primary Outcomes (1)

  • Clinical and PCR-controlled parasitological cure rate at day 28

    28 days

Secondary Outcomes (7)

  • Clinical and PCR-controlled parasitological cure rate at day 14

    14 days

  • Effect on anaemia

    28 days

  • Molecular Drug Resistance Markers

    28 days

  • Recrudescence and Reinfection

    28 days

  • Effects on Gametocytemia

    28 days

  • +2 more secondary outcomes

Study Arms (2)

AL

EXPERIMENTAL

Artemether plus Lumefantrine 6 dose 3 days treatment

Drug: Artemether-Lumefantrine

ASAQ

ACTIVE COMPARATOR

Artesunate plus Amodiaquine

Drug: Artesunate plus Amodiaquine

Interventions

Artesunate plus AmodiaquineDRUG

Artesunate 50 mg and Amodiaquine 153 mg co-blister tablets: 3 days once daily weight-adjusted dosing according to manufacturer

Also known as: Arsucam®
ASAQ
Artemether-LumefantrineDRUG

Artemether 20 mg/Lumefantrine 120mg fixe-dose-combination tablets: 3 days twice daily weight-adjusted dosing according to manufacturer

Also known as: Coartem®
AL

Eligibility Criteria

Age6 Months - 59 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Male and female outpatients aged 6 months to 59 months
  • Absence of severe malnutrition
  • A slide-confirmed P. falciparum asexual parasitaemia between 2,000/µl and 200,000/µl
  • A measured axillary temperature ≥ 37.5 °C or rectal/tympanic temperature ≥ 38.0 °C
  • Absence of general danger signs (unable to drink; repeated vomiting; recent history of convulsions; lethargic or unconscious state; unable to stand up or to sit)
  • Ability to tolerate oral therapy
  • Permanent residence in study area
  • Informed consent by the legal representative of the subject, if possible, the parents

You may not qualify if:

  • Adequate anti-malarial treatment within the previous 7 days
  • Antibiotic treatment for a current infection
  • Previous participation in a clinical trial
  • Haemoglobin \< 5 g/dl
  • Leucocyte count: \> 15000/µl
  • Mixed plasmodial infection
  • Severe malaria as defined by WHO recommendations
  • Any other severe underlying disease (cardiac, renal, hepatic diseases, malnutrition, known HIV infection) or concomitant disease masking assessment of response
  • History of allergy or intolerance against trial medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Agogo Presbyterian Hospital

Agogo, Asante Akim North District, Ghana

Location

Related Publications (6)

  • Bukirwa H, Yeka A, Kamya MR, Talisuna A, Banek K, Bakyaita N, Rwakimari JB, Rosenthal PJ, Wabwire-Mangen F, Dorsey G, Staedke SG. Artemisinin combination therapies for treatment of uncomplicated malaria in Uganda. PLoS Clin Trials. 2006 May;1(1):e7. doi: 10.1371/journal.pctr.0010007. Epub 2006 May 19.

    PMID: 16871329BACKGROUND

  • Mutabingwa TK, Anthony D, Heller A, Hallett R, Ahmed J, Drakeley C, Greenwood BM, Whitty CJ. Amodiaquine alone, amodiaquine+sulfadoxine-pyrimethamine, amodiaquine+artesunate, and artemether-lumefantrine for outpatient treatment of malaria in Tanzanian children: a four-arm randomised effectiveness trial. Lancet. 2005 Apr 23-29;365(9469):1474-80. doi: 10.1016/S0140-6736(05)66417-3.

    PMID: 15850631BACKGROUND

  • Makanga M, Premji Z, Falade C, Karbwang J, Mueller EA, Andriano K, Hunt P, De Palacios PI. Efficacy and safety of the six-dose regimen of artemether-lumefantrine in pediatrics with uncomplicated Plasmodium falciparum malaria: a pooled analysis of individual patient data. Am J Trop Med Hyg. 2006 Jun;74(6):991-8.

    PMID: 16760509BACKGROUND

  • Price RN, Uhlemann AC, van Vugt M, Brockman A, Hutagalung R, Nair S, Nash D, Singhasivanon P, Anderson TJ, Krishna S, White NJ, Nosten F. Molecular and pharmacological determinants of the therapeutic response to artemether-lumefantrine in multidrug-resistant Plasmodium falciparum malaria. Clin Infect Dis. 2006 Jun 1;42(11):1570-7. doi: 10.1086/503423. Epub 2006 Apr 26.

    PMID: 16652314BACKGROUND

  • Martensson A, Stromberg J, Sisowath C, Msellem MI, Gil JP, Montgomery SM, Olliaro P, Ali AS, Bjorkman A. Efficacy of artesunate plus amodiaquine versus that of artemether-lumefantrine for the treatment of uncomplicated childhood Plasmodium falciparum malaria in Zanzibar, Tanzania. Clin Infect Dis. 2005 Oct 15;41(8):1079-86. doi: 10.1086/444460. Epub 2005 Sep 13.

    PMID: 16163624BACKGROUND

  • Sidhu AB, Uhlemann AC, Valderramos SG, Valderramos JC, Krishna S, Fidock DA. Decreasing pfmdr1 copy number in plasmodium falciparum malaria heightens susceptibility to mefloquine, lumefantrine, halofantrine, quinine, and artemisinin. J Infect Dis. 2006 Aug 15;194(4):528-35. doi: 10.1086/507115. Epub 2006 Jul 11.

    PMID: 16845638BACKGROUND

Related Links

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

ArtesunateAmodiaquineArtemether, Lumefantrine Drug Combination

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

ArtemisininsReactive Oxygen SpeciesFree RadicalsInorganic ChemicalsOrganic ChemicalsSesquiterpenesTerpenesHydrocarbonsAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsArtemetherLumefantrineFluorenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Daniel Ansong, MD

    School of Medical Science (SMS), Kwame Nkrumah University of Science and Technology (KNUST), Kumasi, Ghana

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 8, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Study Completion

October 1, 2007

Last Updated

November 27, 2007

Record last verified: 2007-11

Locations

GH(1)