ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ISRCTN
Last refreshed on:	25 November 2019
Main ID:	ISRCTN75343446
Date of registration:	19/08/2002
Prospective Registration:	No
Primary sponsor:	Medical Research Council (MRC) (UK)
Public title:	Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors
Scientific title:	Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors
Date of first enrolment:	01/06/1997
Target sample size:	200
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN75343446
Study type:	Interventional
Study design:	Randomised controlled trial (Not Specified)
Phase:	Not Specified

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	- -
Address:	UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road NW1 2DA London United Kingdom
Telephone:
Email:
Affiliation:

Key inclusion & exclusion criteria

Inclusion criteria:
1. Patients entered into the MRC trials AML 11, AML 12, or UKALL XII, or their successors
2. The following classification of fungal infection in leukaemia patients eligible for this trial are
a. Pulmonary fungal infection - proven or suspected
b. Sinus infected - proven or suspected
c. Fungemia - suspected
d. Chronic hepatosplenic candidosis - proven by Computed Tomography (CT)/Magnetic Resonance Imaging (MRI)
e. Invasive cutaneous infection - proven
f. Cerebral fungal infection - proven or suspected
3. Karnofsky performance status of at least 30%
4. Patients with known intolerance to either test drug are excluded
5. Previous use of AmBisome within 2 weeks, or use of granulocyte-macrophage colony-stimulating factor (GM-CSF) within 3 months excludes a patient
6. Life expectancy of >6 weeks
7. Aged >15 years

Exclusion criteria: Not provided at time of registration

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Leukaemia (acute)
Cancer
Leukaemia (acute)

Intervention(s)

1. Arm A: Placebo given by subcutaneous injection plus liposomal amphoterecin (AmBisome) at a dose of 3 mg/Kg per day by intravenous infusion for those with proven infection and 1 mg/Kg per day by intravenous infusion for those with suspected infection.

2. Arm B: GM-CSF at an initial dose of 5 µg/Kg/day by subcutaneous injection plus liposomal amphoterecin (AmBisome) at an initial dose of 3 mg/Kg/day by intravenous infusion for those with proven infection and 1 mg/Kg/day by intravenous infusion for those with suspected infection.

Primary Outcome(s)

1. Resolution of fever
2. Resolution of radiological and microbiological signs of infection

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

G8223452 - MRC IFI

Source(s) of Monetary Support

Medical Research Council (MRC) (UK), Norvartis Pharmaceuticals (UK), Nexstar Pharmaceuticals (UK)

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Not provided at time of registration

Results

Results available:	Yes
Date Posted:
Date Completed:	30/06/1997
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.