NCT00167739

Brief Summary

Quinine remains the treatment of choice of hospitalised malaria cases. The long treatment duration of 7 days, and adverse reactions often hamper its adequate use. Reducing the treatment duration by adding sulfadoxine-pyrimethamine may enhance compliance and reduce side effects. The efficacy of a 3-day treatment of quinine plus sulfadoxine-pyrimethamine for the treatment of hospitalised, uncomplicated malaria cases was assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2003

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

April 1, 2003

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
Last Updated

September 21, 2005

Status Verified

September 1, 2005

First QC Date

September 11, 2005

Last Update Submit

September 19, 2005

Conditions

Malaria

Keywords

MalariaQuinineSulfadoxine-pyrimethamineGabon

Outcome Measures

Primary Outcomes (1)

  • Proportion of cured patients by day 28

Secondary Outcomes (4)

  • Proportion of gametocytes carriers during the hospitalisation period and on days 7, 14, 21, and 28

  • Parasite clearance time

  • Fever clearance time

  • Assessment of adverse events during the study period

Interventions

Quinine plus sulfadoxine-pyrimethamineDRUG

Eligibility Criteria

Age2 Years - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Uncomplicated falciparum malaria
  • Asexual parasitaemia between 20,000 and 200,000/µL
  • No mixed plasmodial infection
  • Fever with temperature above 38 °C or history of fever during the preceding 24 hours
  • No effective anti-malarial treatment for the present attack
  • Informed consent

You may not qualify if:

  • Haemoglobin \< 7 g/dL
  • Packed-cell volume \< 20%
  • White cell count \> 16,000/µL
  • Platelet count \< 40,000/µL
  • Schizontaemia \> 50/µL
  • Impaired consciousness
  • Convulsions or history of convulsions
  • Concomitant diseases masking assessment of response

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Research Unit, Lambaréné

Lambaréné, Moyen-Ogooué Province, B.P. 118, Gabon

Location

Related Publications (11)

  • Kremsner PG, Winkler S, Brandts C, Neifer S, Bienzle U, Graninger W. Clindamycin in combination with chloroquine or quinine is an effective therapy for uncomplicated Plasmodium falciparum malaria in children from Gabon. J Infect Dis. 1994 Feb;169(2):467-70. doi: 10.1093/infdis/169.2.467.

    PMID: 8106787BACKGROUND

  • Alloueche A, Bailey W, Barton S, Bwika J, Chimpeni P, Falade CO, Fehintola FA, Horton J, Jaffar S, Kanyok T, Kremsner PG, Kublin JG, Lang T, Missinou MA, Mkandala C, Oduola AM, Premji Z, Robertson L, Sowunmi A, Ward SA, Winstanley PA. Comparison of chlorproguanil-dapsone with sulfadoxine-pyrimethamine for the treatment of uncomplicated falciparum malaria in young African children: double-blind randomised controlled trial. Lancet. 2004 Jun 5;363(9424):1843-8. doi: 10.1016/S0140-6736(04)16350-2.

    PMID: 15183620BACKGROUND

  • Bousema JT, Gouagna LC, Meutstege AM, Okech BE, Akim NI, Githure JI, Beier JC, Sauerwein RW. Treatment failure of pyrimethamine-sulphadoxine and induction of Plasmodium falciparum gametocytaemia in children in western Kenya. Trop Med Int Health. 2003 May;8(5):427-30. doi: 10.1046/j.1365-3156.2003.01047.x.

    PMID: 12753638BACKGROUND

  • Kremsner PG, Krishna S. Antimalarial combinations. Lancet. 2004 Jul 17-23;364(9430):285-94. doi: 10.1016/S0140-6736(04)16680-4.

    PMID: 15262108BACKGROUND

  • Athan E, Durrheim DN, Barnes K, Mngomezulu NM, Mabuza A, Govere J. Effectiveness of short-course quinine and single-dose sulfadoxine-pyrimethamine in the treatment of Plasmodium falciparum malaria in Mpumalanga Province, South Africa. S Afr Med J. 2001 Jul;91(7):592-4.

    PMID: 11544977BACKGROUND

  • Rahman MR, Paul DC, Rashid M, Ghosh A, Bangali AM, Jalil MA, Faiz MA. A randomized controlled trial on the efficacy of alternative treatment regimens for uncomplicated falciparum malaria in a multidrug-resistant falciparum area of Bangladesh--narrowing the options for the National Malaria Control Programme? Trans R Soc Trop Med Hyg. 2001 Nov-Dec;95(6):661-7. doi: 10.1016/s0035-9203(01)90108-7.

    PMID: 11816441BACKGROUND

  • Ogutu BR, Nzila AM, Ochong E, Mithwani S, Wamola B, Olola CH, Lowe B, Kokwaro GO, Marsh K, Newton CR. The role of sequential administration of sulphadoxine/pyrimethamine following quinine in the treatment of severe falciparum malaria in children. Trop Med Int Health. 2005 May;10(5):484-8. doi: 10.1111/j.1365-3156.2005.01415.x.

    PMID: 15860096BACKGROUND

  • Deloron P, Mayombo J, Le Cardinal A, Mezui-Me-Ndong J, Bruzi-Baert C, Lekoulou F, Elissa N. Sulfadoxine-pyrimethamine for the treatment of Plasmodium falciparum malaria in Gabonese children. Trans R Soc Trop Med Hyg. 2000 Mar-Apr;94(2):188-90. doi: 10.1016/s0035-9203(00)90272-4.

    PMID: 10897366BACKGROUND

  • Hall AP, Doberstyn EB, Mettaprakong V, Sonkom P. Falciparum malaria cured by quinine followed by sulfadoxine-pyrimethamine. Br Med J. 1975 Apr 5;2(5961):15-7. doi: 10.1136/bmj.2.5961.15.

    PMID: 1093610BACKGROUND

  • Hall AP, Doberstyn EB, Karnchanachetanee C, Samransamruajkit S, Laixuthai B, Pearlman EJ, Lampe RM, Miller CF, Phintuyothin P. Sequential treatment with quinine and mefloquine or quinine and pyrimethamine-sulfadoxine for falciparum malaria. Br Med J. 1977 Jun 25;1(6077):1626-8. doi: 10.1136/bmj.1.6077.1626.

    PMID: 326337BACKGROUND

  • de Souza JM, Sheth UK, de Oliveira RM, Roulet H, de Souza SD. An open, randomized, phase III clinical trial of mefloquine and of quinine plus sulfadoxine-pyrimethamine in the treatment of symptomatic falciparum malaria in Brazil. Bull World Health Organ. 1985;63(3):603-9.

    PMID: 3899397BACKGROUND

Related Links

MeSH Terms

Conditions

Malaria

Interventions

Quininefanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

Cinchona AlkaloidsAlkaloidsHeterocyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michel A. Missinou, PhD

    Albert Schweitzer Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2005

First Posted

September 14, 2005

Study Start

April 1, 2003

Study Completion

February 1, 2004

Last Updated

September 21, 2005

Record last verified: 2005-09

Locations

GA(1)