Condition category
Infections and Infestations
Date applied
22/07/2005
Date assigned
22/07/2005
Last edited
13/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Kathryn Maitland

ORCID ID

Contact details

KEMRI
KEMRI Centre for Geographic Medicine
P.O. Box 230
Kilifi
-
Kenya
+254 (0)73 3411022
kmaitland@kilifi.mimcom.net

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

062258

Study information

Scientific title

Acronym

Study hypothesis

1. To establish to what degree hypovolaemia contributes to the clinical spectrum of severe malaria
2. To establish, through intervention studies, whether the acidosis of severe malaria can be corrected by adequate volume replacement
3. To examine the safety and efficacy of adequate volume replacement and determine the optimum intravenous fluid (0.9% saline or 4.5% albumin) to use in children with severe malaria

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Severe malaria

Intervention

Open phase II randomised trial comparing the safety and efficacy of volume expansion with 0.9% saline or human albumin to control in children with severe malaria and moderate acidosis (base deficit of eight to 15) and comparing safety and efficacy of 0.9% saline and human albumin as volume expansion in children with severe malaria complicated by severe acidosis (base deficit of more than 15).

Intervention type

Other

Phase

Phase II

Drug names

Primary outcome measures

Percentage reduction in acidosis by eight hours.

Secondary outcome measures

1. Death
2. Severe adverse events
3. Neurological sequalae

Overall trial start date

01/05/2001

Overall trial end date

01/10/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. A clinical feature of severe malaria (prostration, coma or deep breathing) plus P. falciparum
2. A base deficit of more than eight
3. Parental consent

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

To be added

Participant exclusion criteria

1. Clinical features of oedematous malnutrition
2. Features suggestive of pulmonary oedema (oxygen saturations <90% and bilateral creptitations)
3. Raised intracranial pressure (unequal pupillary reaction to light and/or raised blood pressure concurrent with bradycardia)
3. Refusal of consent

Recruitment start date

01/05/2001

Recruitment end date

01/10/2002

Locations

Countries of recruitment

Kenya

Trial participating centre

KEMRI
Kilifi
-
Kenya

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

Level 2
Faculty Building
Clinical Research Office
South Kensington campus
London
SW7 2AZ
United Kingdom
clinical.researchoffice@imperial.ac.uk

Sponsor type

University/education

Website

http://www3.imperial.ac.uk/

Funders

Funder type

Charity

Funder name

The Wellcome Trust (UK) (grant ref: 062258)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes