Condition category
Cancer
Date applied
27/09/2004
Date assigned
05/01/2005
Last edited
13/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Oliver Cornely

ORCID ID

Contact details

University Hospital of Cologne
Department of Internal Medicine
Cologne
50924
Germany
+49 221 478 6209
oliver.cornely@uni-koeln.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NRA 150 0009

Study information

Scientific title

Acronym

Voriconazole prophylaxis

Study hypothesis

Voriconazole is superior to placebo in the prophylaxis of lung infiltrates until day 21 after start of induction chemotherapy.

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

Prevention

Patient information sheet

Condition

Acute Myelogenous Leukaemia (AML)

Intervention

Voriconazole 200 mg twice a day (bid) orally (po) or placebo

This trial was prematurely terminated on 19 January 2006 due to establishment of a new standard treatment, which made the placebo group of the trial ethically unjustifiable.

Intervention type

Drug

Phase

Phase III

Drug names

Voriconazole

Primary outcome measures

Incidence of lung infiltrates

Secondary outcome measures

1. Incidence of fever and other signs of infection
2. Incidence and type of documented bacteremia
3. Rate of patients with systemic open-label antifungal therapy
4. Time to initiation of systemic open-label antifungal therapy
5. Duration of absolute neutrophil count <500/µl
6. Rate and type of proven, probable and possible breakthrough invasive fungal infections
7. Rate of patients with fever of unknown origin
8. Incidence and severity of adverse events
9. Trough voriconazole plasma level
10. Direct costs of systemic antibiotics, antifungals and antivirals and diagnostic imaging
11. Overall costs in terms of the diagnosis related groups applied to the study patients

Overall trial start date

01/11/2004

Overall trial end date

31/12/2007

Reason abandoned

This trial was prematurely terminated on 19 January 2006 due to establishment of a new standard treatment, which made the placebo group of the trial ethically unjustifiable.

Eligibility

Participant inclusion criteria

Patients with first induction chemotherapy for acute myelogenous leukaemia (AML):
1. Newly diagnosed or relapsed, de novo or secondary AML
2. First induction chemotherapy cycle
3. Expected neutropenic phase of a minimum duration of 10 days
4. Age greater than 18 years
5. Legally signed informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Planned: 150 patients, analyzed: 25 patients.

Participant exclusion criteria

1. Known proven, probable or possible invasive fungal infection at randomization or in patient history
2. CT with any signs of a fungal infection according to the EORTC/MSG criteria, i.e. with any infiltrate (Ascioglu, et al 2002)
3. Any current fever unless explained by non-infectious causes
4. Antibacterial prophylaxis other than TMP/SMX
5. LFT (AST/ALT/bilirubin) more than 3x the upper normal limit
6. Subjects who are receiving and cannot discontinue one of the following drugs at least 24 hours prior to randomization:
6.1. Drugs with a known possibility of QTc prolongation (e.g. terfenadine, astemizole, cisapride, pimozide, quinidine)
6.2. Drugs whose plasma levels may be increased by voriconazole therapy (e.g. sulphonylureas, ergot alkaloids, sirolimus, vinca alkaloids)
7. Subjects who have received the following drugs within 14 days prior to randomization: Potent inducers of hepatic enzymes that will reduce voriconazole levels (e.g. rifampicin, carbamazepine and barbiturates)
8. Concomitant therapy with absorbable antifungals
9. Patient has a diagnosis of acute hepatitis or cirrhosis due to any cause
10. Known hypersensitivity or other contraindication to voriconazole
11. Patient unwilling or unable to comply with the protocol
12. Diseases or disabilities preventing the patient from participating in the trial
13. Females of childbearing potential without negative serum pregnancy test at baseline or within 72 hours prior to start of study drug

Ascioglu S, Rex JH, de Pauw B, Bennett JE, Bille J, Crokaert F, Denning DW, Donnelly JP, Edwards JE, Erjavec Z, Fiere D, Lortholary O, Maertens J, Meis JF, Patterson TF, Ritter J, Selleslag D, Shah PM, Stevens DA, Walsh TJ; Invasive Fungal Infections Cooperative Group of the European Organization for Research and Treatment of Cancer; Mycoses Study Group of the National Institute of Allergy and Infectious Diseases. Defining opportunistic invasive fungal infections in immunocompromised patients with cancer and hematopoietic stem cell transplants: an international consensus. Clin Infect Dis. 2002 Jan 1;34(1):7-14.

Recruitment start date

01/11/2004

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital of Cologne
Cologne
50924
Germany

Sponsor information

Organisation

University Hospital of Cologne (Germany)

Sponsor details

Kerpener Strasse 62
Cologne
50924
Germany

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

Pfizer GmbH, Karlsruhe (Germany)

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