A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections - Study Results

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Condition:	Systemic Fungal Infections
Intervention:	Drug: voriconazole

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups

	Description
Voriconazole Antifungal Treatment	Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.
Other Antifungal Treatment	Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study.

Participant Flow: Overall Study

	Voriconazole Antifungal Treatment	Other Antifungal Treatment
STARTED	12	11
COMPLETED	10	9
NOT COMPLETED	2	2
Death	1	1
Withdrawal by Subject	1	1

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Entire Study Population	Systemic antifungals were administered based on approved prescribing documents and were adjusted solely according to medical and therapeutic necessity. The choice of systemic antifungal agent was dependent on the investigators decision and was independent of enrollment into the study

Baseline Measures

	Entire Study Population
Number of Participants [units: participants]	23
Age [units: Participants]
<=18 years	0
Between 18 and 65 years	16
>=65 years	7
Gender [units: Participants]
Female	6
Male	17

Outcome Measures

Show All Outcome Measures

1. Primary:

Diagnosis of Systemic Fungal Infection (SFI) [ Time Frame: Up to 9 months ]

Show Outcome Measure 1

2. Primary:

Management of SFI: Choice of Treatment [ Time Frame: Up to 9 months ]

Show Outcome Measure 2

3. Primary:

Management of SFI: Reason for Selection of Antifungal Agent [ Time Frame: Up to 9 months ]

Show Outcome Measure 3

4. Primary:

Total Daily Dose for Selected Antifungal Agent [ Time Frame: Up to 9 months ]

Show Outcome Measure 4

5. Primary:

Number of Participants With Clinical Outcomes. [ Time Frame: Up to 9 months ]

Show Outcome Measure 5

6. Primary:

Number of Participants With Mycological Outcomes [ Time Frame: Up to 9 months ]

Show Outcome Measure 6

7. Secondary:

Concomitant Medications [ Time Frame: Up to 9 months ]

Show Outcome Measure 7

8. Secondary:

Median Duration of Antifungal Therapy [ Time Frame: Up to 9 months ]

Show Outcome Measure 8

9. Secondary:

Medication Administration [ Time Frame: Up to 9 months ]

Show Outcome Measure 9

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Primary and Secondary outcome measured were arbitrarily defined as they were not defined in the protocol. This study was terminated prematurely due to slow recruitment rate leading to a small (23) number of subjects analyzed.

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data

Primary and Secondary outcome measured were arbitrarily defined as they were not defined in the protocol.

This study was terminated prematurely due to slow recruitment rate leading to a small (23) number of subjects analyzed.

Results Point of Contact:

Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT00721578 History of Changes
Other Study ID Numbers:	A1501089
Study First Received:	July 22, 2008
Results First Received:	July 28, 2010
Last Updated:	January 6, 2011
Health Authority:	India: Institutional Review Board