Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by Makerere University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Sanofi-Synthelabo
Ministry of Health, Uganda
Information provided by:
Makerere University
ClinicalTrials.gov Identifier:
NCT00124267
First received: July 26, 2005
Last updated: August 3, 2005
Last verified: July 2005
  Purpose

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.


Condition Intervention Phase
Cerebral Malaria
Drug: Intrarectal quinine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy of Intrarectal Versus Intravenous Quinine for the Treatment of Childhood Cerebral Malaria: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Makerere University:

Primary Outcome Measures:
  • Parasite clearance time

Secondary Outcome Measures:
  • Fever clearance time
  • Coma recovery time
  • Time to sit unsupported
  • Time to begin oral intake
  • Mortality
  • Neurological sequelae
  • Adverse drug events

Estimated Enrollment: 108
Study Start Date: September 2003
Estimated Study Completion Date: January 2004
Detailed Description:

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. A few studies in Francophone Africa have reported clinical efficacy and tolerance of intrarectal quinine. Although the studies were randomized trials, they were not blinded and did not use the WHO definition of cerebral malaria as selection criteria.

The current study aims to establish whether intrarectal quinine is as effective and as safe as intravenous quinine in the treatment of childhood cerebral malaria.

To address the shortcomings of the Francophone African studies, the investigators have designed a randomized, double blind placebo controlled clinical trial to include patients who meet the WHO definition of cerebral malaria.

Hypothesis:

Intrarectal quinine (15mg/kg every 8 hours) given to children with cerebral malaria, will lead to a shorter parasite clearance time (39.9 hours) than intravenous quinine (55.0 hours).

The investigators calculated a sample size of 54 patients in each group for 90% power and 95% confidence. In the calculation, the researchers assumed that the children receiving intrarectal quinine would have a mean parasite clearance time of 39.9 (SD 24.3) hours and those receiving intravenous quinine would have a mean parasite clearance time of 55.0(SD 24.3) hours (27.5% effect size), according to a study by Aceng, Byarugaba and Tumwine in the same hospital.

  Eligibility

Ages Eligible for Study:   6 Months to 5 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00124267

Locations
Uganda
Mulago Hospital
Kampala, Uganda, 7051
Sponsors and Collaborators
Makerere University
Sanofi-Synthelabo
Ministry of Health, Uganda
Investigators
Principal Investigator: Jane Achan, MBChB Department of Paediatrics and Child Health, Makerere University
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00124267     History of Changes
Other Study ID Numbers: 2001/HD11/524/RQ
Study First Received: July 26, 2005
Last Updated: August 3, 2005
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Makerere University:
Cerebral
malaria
intra-rectal
quinine
children
Uganda
efficacy
safety

Additional relevant MeSH terms:
Malaria
Malaria, Cerebral
Protozoan Infections
Parasitic Diseases
Central Nervous System Protozoal Infections
Central Nervous System Parasitic Infections
Malaria, Falciparum
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

ClinicalTrials.gov processed this record on July 29, 2014