Mannitol as Adjunct Therapy for Childhood Cerebral Malaria

NCT00113854 | Unknown Phase 3

• 1 other identifier: HD200211/246
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Cerebral malaria is a life-threatening complication of Plasmodium falciparum infection in African children and nonimmune travellers despite availability of quinine, the current drug of choice. Several reports have suggested that raised intracranial pressure (ICP) is a major cause of death among children with cerebral malaria. Mannitol, an osmotic diuretic, effectively lowers ICP and is used to treat post traumatic raised ICP. There have been some case reports of reduction in mortality and morbidity in African children with cerebral malaria following administration of mannitol, but as these were not randomized controlled trials it is difficult to evaluate their significance. This study seeks to establish whether a single dose of intravenous mannitol given to children with cerebral malaria will significantly reduce the coma recovery time.

Conditions

Cerebral Malaria

Keywords

cerebral; malaria; children; mannitol; adjunct; therapy; Uganda

Outcome Measures

Primary Outcomes (1)

• Coma recovery time (that is time from beginning of antimalarial treatment until patient has fully regained consciousness).

Secondary Outcomes (5)

• Time taken to sit un supported

• Time to begin oral intake

• Duration of hospitalisation

• Mortality

• Proportion of children recovering with neurological sequelae

Interventions

Mannitol DRUG

Eligibility Criteria

• Age: 6 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 6 months to 5 years admitted to the Mulago hospital acute care unit during the study period with cerebral malaria: (seizures and unarousable coma lasting more than 30 minutes after seizures have stopped, with asexual forms of P. falciparum on the blood film, with no other cause of coma) and whose carers gave informed consent.

You may not qualify if:

• Children with evidence of having received any sedation within two hours prior to admission to the acute care unit.
• Also exclude children with clinical signs of pulmonary congestion, or heart failure, or renal disease, or shock

Sponsors & Collaborators

• Makerere University: lead

Study Sites (1)

Department of Paediatrics and Child Health, Makerere Medical School

Kampala, Kampala, P O Box 7072, Uganda

Location

Related Publications (5)

• 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: 15705690 BACKGROUND

• Newton CR, Crawley J, Sowumni A, Waruiru C, Mwangi I, English M, Murphy S, Winstanley PA, Marsh K, Kirkham FJ. Intracranial hypertension in Africans with cerebral malaria. Arch Dis Child. 1997 Mar;76(3):219-26. doi: 10.1136/adc.76.3.219.

  PMID: 9135262 BACKGROUND

• Newton CR, Kirkham FJ, Winstanley PA, Pasvol G, Peshu N, Warrell DA, Marsh K. Intracranial pressure in African children with cerebral malaria. Lancet. 1991 Mar 9;337(8741):573-6. doi: 10.1016/0140-6736(91)91638-b.

  PMID: 1671941 BACKGROUND

• Okoromah CA, Afolabi BB. Mannitol and other osmotic diuretics as adjuncts for treating cerebral malaria. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD004615. doi: 10.1002/14651858.CD004615.pub2.

  PMID: 15495121 BACKGROUND

• Namutangula B, Ndeezi G, Byarugaba JS, Tumwine JK. Mannitol as adjunct therapy for childhood cerebral malaria in Uganda: a randomized clinical trial. Malar J. 2007 Oct 24;6:138. doi: 10.1186/1475-2875-6-138.

  PMID: 17958887 DERIVED

MeSH Terms

Conditions

Malaria, Cerebral; Malaria

Interventions

Mannitol

Condition Hierarchy (Ancestors)

Central Nervous System Protozoal Infections; Central Nervous System Parasitic Infections; Central Nervous System Infections; Infections; Parasitic Diseases; Protozoan Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

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: June 10, 2005
• First Posted: June 13, 2005
• Study Start: October 1, 2004
• Study Completion: May 1, 2005
• Last Updated: June 24, 2005

Record last verified: 2005-06

Locations

UG (1)