NCT00124267

Brief Summary

Cerebral malaria is the most lethal complication of P.falciparum infection with a mortality rate between 5 and 40%. Intravenous quinine remains the recommended treatment for cerebral malaria. However its administration is often not feasible due to lack of simple equipment or trained staff. When referral is not possible, a viable alternative is needed. The intrarectal route is of interest in children since it is painless and simple. Studies of the efficacy of intrarectal quinine in the treatment of cerebral malaria are limited. The study aims to establish the efficacy of intrarectal quinine in the treatment of childhood cerebral malaria.

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
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Sep 2003

Shorter than P25 for phase_3

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

September 1, 2003

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2005

Completed
Last Updated

August 4, 2005

Status Verified

July 1, 2005

First QC Date

July 26, 2005

Last Update Submit

August 3, 2005

Conditions

Cerebral Malaria

Keywords

Cerebralmalariaintra-rectalquininechildrenUgandaefficacysafety

Outcome Measures

Primary Outcomes (1)

  • Parasite clearance time

Secondary Outcomes (7)

  • Fever clearance time

  • Coma recovery time

  • Time to sit unsupported

  • Time to begin oral intake

  • Mortality

  • +2 more secondary outcomes

Interventions

Intrarectal quinineDRUG

Eligibility Criteria

Age6 Months - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6 months to 5 years admitted to Mulago hospital during the study period who satisfy the World Health Organization (WHO) case definition of cerebral malaria (Unarousable coma lasting more than 30 minutes after a seizure, with peripheral asexual P.falciparum parasitaemia and absence of other causes of coma) and whose caretakers give informed consent.

You may not qualify if:

  • Patients with diarrhea (more than 4 motions/24 hours)
  • Any recent anal pathology (such as rectal bleeding, rectal prolapse)
  • Documented quinine treatment in previous 48 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mulago Hospital

Kampala, Kampala, 7051, Uganda

Location

Related Publications (6)

  • Pussard E, Straczek C, Kabore I, Bicaba A, Balima-Koussoube T, Bouree P, Barennes H. Dose-dependent resorption of quinine after intrarectal administration to children with moderate Plasmodium falciparum malaria. Antimicrob Agents Chemother. 2004 Nov;48(11):4422-6. doi: 10.1128/AAC.48.11.4422-4426.2004.

    PMID: 15504872BACKGROUND

  • Barennes H, Sterlingot H, Nagot N, Meda H, Kabore M, Sanou M, Nacro B, Bouree P, Pussard E. Intrarectal pharmacokinetics of two formulations of quinine in children with falciparum malaria. Eur J Clin Pharmacol. 2003 Feb;58(10):649-52. doi: 10.1007/s00228-002-0546-2. Epub 2003 Jan 29.

    PMID: 12610739BACKGROUND

  • Barennes H, Munjakazi J, Verdier F, Clavier F, Pussard E. An open randomized clinical study of intrarectal versus infused Quinimax for the treatment of childhood cerebral malaria in Niger. Trans R Soc Trop Med Hyg. 1998 Jul-Aug;92(4):437-40. doi: 10.1016/s0035-9203(98)91083-5.

    PMID: 9850403BACKGROUND

  • Aceng JR, Byarugaba JS, Tumwine JK. Rectal artemether versus intravenous quinine for the treatment of cerebral malaria in children in Uganda: randomised clinical trial. BMJ. 2005 Feb 12;330(7487):334. doi: 10.1136/bmj.330.7487.334.

    PMID: 15705690BACKGROUND

  • Simoes EA, Peterson S, Gamatie Y, Kisanga FS, Mukasa G, Nsungwa-Sabiiti J, Were MW, Weber MW. Management of severely ill children at first-level health facilities in sub-Saharan Africa when referral is difficult. Bull World Health Organ. 2003;81(7):522-31. Epub 2003 Sep 3.

    PMID: 12973645BACKGROUND

  • Nakibuuka V, Ndeezi G, Nakiboneka D, Ndugwa CM, Tumwine JK. Presumptive treatment with sulphadoxine-pyrimethamine versus weekly chloroquine for malaria prophylaxis in children with sickle cell anaemia in Uganda: a randomized controlled trial. Malar J. 2009 Oct 24;8:237. doi: 10.1186/1475-2875-8-237.

    PMID: 19852829DERIVED

MeSH Terms

Conditions

Malaria, CerebralMalaria

Condition Hierarchy (Ancestors)

Central Nervous System Protozoal InfectionsCentral Nervous System Parasitic InfectionsCentral Nervous System InfectionsInfectionsParasitic DiseasesProtozoan InfectionsMosquito-Borne DiseasesVector Borne DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Jane Achan, MBChB

    Department of Paediatrics and Child Health, Makerere University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 26, 2005

First Posted

July 27, 2005

Study Start

September 1, 2003

Study Completion

January 1, 2004

Last Updated

August 4, 2005

Record last verified: 2005-07

Locations

UG(1)