Systemic Fungal InfectionsNCT00721578

A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

An observational study of Systemic Fungal Infections, run by Pfizer at 3 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To collect and summarize information on the diagnosis, management, and clinical and mycological outcomes of patients with systemic fungal infections in order to better understand the effectiveness of antifungals in the treatment of Systemic Fungal Infections (SFI) in India. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Systemic Fungal Infections
What is being tested?: voriconazole
How many people: 23 participants
Where: 3 sitesIndia
Study dates: Apr 2009to Dec 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.

Who may be able to join

To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.

Who cannot join

None.

Trial locations and contacts

3 sites in 1 country.

India3 sites

Pfizer Investigational Site
New Delhi, New Delhi, 110 076
Pfizer Investigational Site
Pune, Maharashtra, 411 001
Pfizer Investigational Site
Pune, Maharashtra, 411004

Other trials in India

About this study

Official title: An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections

Conditions: Systemic Fungal Infections
Being tested: voriconazole
Keywords: Observational study, Effectiveness, Safety, Tolerability, Systemic Fungal Infection

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

voriconazoleDrug
Also called Vfend
Patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.

Study groups in NCT00721578
Study group	Role	What they receive
1		Not described Receives: Drug: voriconazole

What is being measured

The primary outcome is the main question the study is designed to answer.

Diagnosis of Systemic Fungal Infection (SFI)
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Measured: Up to 9 months
Management of SFI: Choice of Treatment
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Measured: Up to 9 months
Management of SFI: Reason for Selection of Antifungal Agent
Number of participants with reason for investigator's selection of particular antifungal therapy.
Measured: Up to 9 months
Total Daily Dose for Selected Antifungal Agent
Measured: Up to 9 months
Number of Participants With Clinical Outcomes.
Clinical outcomes, as assessed by the investigator, defined as:
Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period.
Deteriorated: clinical signs and symptoms of fungal infection worsened (including death).
Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation.
Measured: Up to 9 months
Number of Participants With Mycological Outcomes
Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy
), or unknown (results are not available/not known) as assessed by the Investigator/Physician.
Measured: Up to 9 months

Secondary outcomes (3)

Concomitant Medications
Measured: Up to 9 months
Median Duration of Antifungal Therapy
Measured: Up to 9 months
Medication Administration
Participants who received medication by IV or oral administration, reported by total number of participants receiving IV and total number of participants receiving oral administation (overall), and by total number of participants receiving voriconazole only by IV or oral administration.
Measured: Up to 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2009Dec 2009

First posted24 Jul 2008 (estimated)
Study startApr 2009
Primary completionDec 2009
Study completionDec 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Systemic Fungal InfectionsStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00721578
Sponsor's protocol ID: A1501089
Status last verified: Jan 2011
First submitted: 22 Jul 2008
Last updated: 10 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Fungal Infections trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
ClinicalTrials.gov ID: NCT00721578
Acronym / sponsor ID: A1501089
Conditions: Systemic Fungal Infections
Keywords: Observational study, Effectiveness, Safety, Tolerability, Systemic Fungal Infection
Study type: Observational
Recruitment status: Completed
Enrolment: 23 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2009
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009 (actual)
First posted: 24 Jul 2008 (estimated)
Results: Posted 26 Aug 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
1	–	Drug: voriconazole

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: A database of outcomes in patients with proven or probable Systemic Fungal Infections (SFI) treated with antifungals in 5 centers across India.

Key inclusion criteria (1 listed)

To be eligible for enrollment in the study database, patients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection.

Key exclusion criteria (1 listed)

None.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
voriconazoleAlso: VfendPatients must have received (in the Intensive Care Unit [ICU] at study entry) at least 1 day therapy with systemic antifungal agent for treatment of a proven or suspected fungal infection. The decision regarding choice of antifungal agent would lie with the treating physician and will necessarily precede and be independent of the decision to enroll a patient into the study.	Drug	1

Primary outcome

Diagnosis of Systemic Fungal Infection (SFI)
Time frame: Up to 9 months
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Management of SFI: Choice of Treatment
Time frame: Up to 9 months
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Management of SFI: Reason for Selection of Antifungal Agent
Time frame: Up to 9 months
Number of participants with reason for investigator's selection of particular antifungal therapy.
Total Daily Dose for Selected Antifungal Agent
Time frame: Up to 9 months
Number of Participants With Clinical Outcomes.
Time frame: Up to 9 months
Clinical outcomes, as assessed by the investigator, defined as: Cured: clinical signs and symptoms of fungal infection absent. Improved: clinical signs and symptoms of fungal infection improved. Stable: no change in overall clinical findings, compared with previous reporting period. Deteriorated: clinical signs and symptoms of fungal infection worsened (including death). Indeterminate; clinical signs and symptoms of fungal infection were insufficient to make an evaluation.
Number of Participants With Mycological Outcomes
Time frame: Up to 9 months
Mycological outcome of persistence (continued presence of fungi on microbiology despite therapy), eradication (absence of fungi after therapy ), or unknown (results are not available/not known) as assessed by the Investigator/Physician.

3 secondary outcomes

Concomitant Medications
Time frame: Up to 9 months
Median Duration of Antifungal Therapy
Time frame: Up to 9 months
Medication Administration
Time frame: Up to 9 months

Results and safety

Results posted to the registry on 26 Aug 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Voriconazole Antifungal Treatment	12	10
Other Antifungal Treatment	11	9

Primary outcome: Diagnosis of Systemic Fungal Infection (SFI)

Time frame: Up to 9 months. Number. Unit: Participants

Measure	All Antifungal Therapies n = 23
Fever	20
Hypotension	6
Radiological Assessment (SOT - Abnormal)	18
Radiological Assessment (EOT - Abnormal)	3
Microbiological Assessment (positive, n=7)	5
Microbiological Assessment (negative, n=7)	2

Population analysed: Full analysis set (FAS) = all enrolled participants who received at least one dose of antifungal therapy. n = number of participants who had microbiological assessments performed. SOT = start of treatment, EOT = end of treatment

Primary outcome: Management of SFI: Choice of Treatment

Time frame: Up to 9 months. Number. Unit: Participants

Measure	All Antifungal Therapies n = 23
Voriconazole	12
Fluconazole	11
Caspofungin acetate	3
Amphotericine B, liposome	3
Amphotericin B	2
Caspofungin	1

Population analysed: FAS.

Primary outcome: Management of SFI: Reason for Selection of Antifungal Agent

Time frame: Up to 9 months. Number. Unit: Participants

Population analysed: FAS. Data were not analyzed.

Primary outcome: Total Daily Dose for Selected Antifungal Agent

Time frame: Up to 9 months. Number. Unit: mg

Population analysed: FAS. Data were not analyzed.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Therapy for Systemic Fungal Infections	5 of 23 (21.7%)	3 of 23 (13%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Fungal Infections, run by Pfizer at 3 sites in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Aug 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diagnosis of Systemic Fungal Infection (SFI) (time frame: Up to 9 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00721578.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2011.