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| Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors |
| Source of record | UK Trials |
| ISRCTN | ISRCTN75343446 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | G8223452 - MRC IFI |
| Public title | Supplementary Study for Patients With Invasive Fungal Infection, Entered Into AML 11, AML 12 and UKALL XII or Their Successors |
| Scientific title | |
| Acronym | N/A |
| Disease/condition/study domain | Leukaemia (acute) |
| Study hypothesis | To assess the effect of GM-CSF on the outcome of fungal infection after treatment for leukaemia |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material | |
| Anticipated start date | 01/06/1997 |
| Anticipated end date | 30/06/1997 |
| Status of trial | Completed |
| Target number of participants | 200 |
| Interventions | Patients are randomised to one of two treatment arms: 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 measure(s) | Resolution of fever. Resolution of radiological and microbiological signs of infection |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Medical Research Council Norvartis Pharmaceuticals Nexstar Pharmaceuticals |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent London United Kingdom W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator MRC Clinical Trials Unit 222 Euston Road London United Kingdom NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN75343446 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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