A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00721578
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Duration (Months): 8
• Patients Per Site: 7.7
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Fungal Infections	Drug: voriconazole

Study Design

• Study Type: Observational
• Actual Enrollment: 23 participants
• Time Perspective: Prospective
• Official Title: An Observational Study Of Patients Receiving Therapy For Systemic Fungal Infections
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Dec 1, 2009
• Actual Study Completion Date: Dec 1, 2009

Arms and Interventions

Arm

Intervention/Treatment

1

Drug: voriconazole; 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.; Other Names: Vfend

Outcome Measures

Primary Outcome Measures

1. Diagnosis of Systemic Fungal Infection (SFI) [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.

2. Management of SFI: Choice of Treatment [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.

3. Management of SFI: Reason for Selection of Antifungal Agent [Up to 9 months]

   Number of participants with reason for investigator's selection of particular antifungal therapy.

4. Total Daily Dose for Selected Antifungal Agent [Up to 9 months]

5. Number of Participants With Clinical Outcomes. [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.

6. Number of Participants With Mycological Outcomes [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.

Secondary Outcome Measures

1. Concomitant Medications [Up to 9 months]

2. Median Duration of Antifungal Therapy [Up to 9 months]

3. Medication Administration [Up to 9 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• None.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Pune	Maharashtra	India	411 001
2	Pfizer Investigational Site	Pune	Maharashtra	India	411004
3	Pfizer Investigational Site	New Delhi		India	110 076

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00721578
• Other Study ID Numbers: A1501089
• First Posted: Jul 24, 2008
• Last Update Posted: Jan 10, 2011
• Last Verified: Jan 1, 2011

• Keywords provided by , ,: Observational study; Effectiveness; Safety; Tolerability; Systemic Fungal Infection
• Additional relevant MeSH terms: Infections; Communicable Diseases; Mycoses; Voriconazole

Study Results

Participant Flow

Arm/Group Title	Voriconazole Antifungal Treatment	Other Antifungal Treatment
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	12	11
COMPLETED	10	9
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Entire Study Population
Arm/Group Description	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
Overall Participants	23
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	16 69.6%
>=65 years	7 30.4%
Sex: Female, Male (Count of Participants)
Female	6 26.1%
Male	17 73.9%

Outcome Measures

1. Primary Outcome

Title	Diagnosis of Systemic Fungal Infection (SFI)
Description	Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	All Antifungal Therapies
Arm/Group Description	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
Measure Participants	23
Fever	20 87%
Hypotension	6 26.1%
Radiological Assessment (SOT - Abnormal)	18 78.3%
Radiological Assessment (EOT - Abnormal)	3 13%
Microbiological Assessment (positive, n=7)	5 21.7%
Microbiological Assessment (negative, n=7)	2 8.7%

2. Primary Outcome

Title	Management of SFI: Choice of Treatment
Description	Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	All Antifungal Therapies
Arm/Group Description	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
Measure Participants	23
Voriconazole	12 52.2%
Fluconazole	11 47.8%
Caspofungin acetate	3 13%
Amphotericine B, liposome	3 13%
Amphotericin B	2 8.7%
Caspofungin	1 4.3%

3. Primary Outcome

Title	Management of SFI: Reason for Selection of Antifungal Agent
Description	Number of participants with reason for investigator's selection of particular antifungal therapy.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS. Data were not analyzed.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	0

4. Primary Outcome

Title	Total Daily Dose for Selected Antifungal Agent
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS. Data were not analyzed.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	0

5. Primary Outcome

Title	Number of Participants With Clinical Outcomes.
Description	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.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	23
Cured	2 8.7%
Improved	11 47.8%
Stable	6 26.1%
Deteriorated	4 17.4%

6. Primary Outcome

Title	Number of Participants With Mycological Outcomes
Description	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.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	23
Persistence	3 13%
Eradication	8 34.8%
Unknown	11 47.8%
Not Recorded	1 4.3%

7. Secondary Outcome

Title	Concomitant Medications
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	23
Acetorphan	1 4.3%
Acetylcysteine	3 13%
Acetylsalycilic acid	2 8.7%
Acetylsalicylic acid/clopidogrel	1 4.3%
Aciclovir	1 4.3%
Allopurinol	1 4.3%
Ambroxol	1 4.3%
Ambroxol Hydrochloride	1 4.3%
Amikacin	4 17.4%
Amiodarone Hydrochloride	2 8.7%
Amlodipine	1 4.3%
Atorvastatin	1 4.3%
Atracurium	1 4.3%
B-Komplex "Leciva"	1 4.3%
Breva	1 4.3%
Budesonide	2 8.7%
Carvedilol	1 4.3%
Cefazolin	1 4.3%
Cefepime	1 4.3%
Cefotaxime	1 4.3%
Cefotaxime/sulbactam	1 4.3%
Ciprofloxacin	1 4.3%
Clindamycin	2 8.7%
Clopidogrel	2 8.7%
Colistin mesilate sodium	2 8.7%
Cordalin/old form/	2 8.7%
Deflazacort	1 4.3%
Diltiazem hydrochloride	1 4.3%
Doripenem	1 4.3%
Doxofylline	1 4.3%
Enalapril maleate	1 4.3%
Enoxaparin	1 4.3%
Epoetin alfa	1 4.3%
Escitalopram	1 4.3%
Esomeprazole	2 8.7%
Esomeprazole magnesium	1 4.3%
Ethambutol	2 8.7%
Fludrocortisone	1 4.3%
Fluoxetine hydrochloride	1 4.3%
Folic acid	1 4.3%
Folinic acid	1 4.3%
Furosemide	2 8.7%
Granulocyte colony stimulating factor	1 4.3%
Haloperidol	2 8.7%
Heparin-fraction, sodium salt	6 26.1%
Hydrocortisone	1 4.3%
Hydrocortisone hydrogen succinate	4 17.4%
Imipenem	2 8.7%
Immunoglobulins	1 4.3%
Insulin glargine	1 4.3%
Isoniazid	1 4.3%
Lactulose	2 8.7%
Lekovit ca	2 8.7%
Levetiracetam	2 8.7%
Levocetirizine	1 4.3%
Levofloxacin	4 17.4%
Linezolid	4 17.4%
Meropenem	8 34.8%
Methylprednisolone	2 8.7%
Metoclopramide hydrochloride	3 13%
Metronidazole	5 21.7%
Moxifloxacin	1 4.3%
Mycophenolate mofetil	1 4.3%
Ofloxacin	1 4.3%
Ondansetron	4 17.4%
Pantoprazole	9 39.1%
Pantoprazole sodium	6 26.1%
Paracetamol	8 34.8%
Pazufloxacin	1 4.3%
Pheniramine maleate	1 4.3%
Phenobarbital	1 4.3%
Phenytoin sodium	2 8.7%
Pip/tazo	1 4.3%
Piperacillin	1 4.3%
Piperacillin/tazobactam	4 17.4%
Polybion	2 8.7%
Polymyxin B	2 8.7%
Polymyxin B sulfate	3 13%
Potassium	2 8.7%
Prednisolone	2 8.7%
Primaxin	1 4.3%
Propylthiouracil	1 4.3%
Prulifloxacin	1 4.3%
Pyridoxine	1 4.3%
Ramipril	2 8.7%
Ranolazine	1 4.3%
Ribolac	1 4.3%
Sertraline	2 8.7%
Simvastatin	1 4.3%
Solifenacin	1 4.3%
Sulperazon	5 21.7%
Teicoplanin	11 47.8%
Tienam	1 4.3%
Tramadol	3 13%
Valproic acid	1 4.3%
Vancomycin	1 4.3%
Vancomycin hydrochloride	1 4.3%
Vitamin B-complex	1 4.3%
Vitamin B12 (cyanocobalamin and derivatives)	1 4.3%

8. Secondary Outcome

Title	Median Duration of Antifungal Therapy
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Therapy for Systemic Fungal Infection
Arm/Group Description	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
Measure Participants	23
All Antifungals	12.0
Voriconazole	13.0

9. Secondary Outcome

Title	Medication Administration
Description	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.
Time Frame	Up to 9 months

Outcome Measure Data

Analysis Population Description

FAS.

Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
Measure Participants	23
All Antifungals Intravenous	17 73.9%
All Antifungals Oral	11 47.8%
Voriconazole Intravenous	5 21.7%
Voriconazole Oral	6 26.1%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Therapy for Systemic Fungal Infections
Arm/Group Description	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
All Cause Mortality
	Therapy for Systemic Fungal Infections
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Therapy for Systemic Fungal Infections
	Affected / at Risk (%)	# Events
Total	5/23 (21.7%)
Gastrointestinal disorders
Pancreatitis	1/23 (4.3%)
General disorders
Multi-organ failure	3/23 (13%)
Infections and infestations
Sepsis	1/23 (4.3%)
Septic shock	2/23 (8.7%)
Nervous system disorders
Coma	1/23 (4.3%)
Somnolence	1/23 (4.3%)
Renal and urinary disorders
Azotaemia	1/23 (4.3%)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease	1/23 (4.3%)
Dyspnoea	1/23 (4.3%)
Other (Not Including Serious) Adverse Events
	Therapy for Systemic Fungal Infections
	Affected / at Risk (%)	# Events
Total	3/23 (13%)
Gastrointestinal disorders
Vomiting	1/23 (4.3%)
Renal and urinary disorders
Urinary incontinence	1/23 (4.3%)
Skin and subcutaneous tissue disorders
Decubitus ulcer	1/23 (4.3%)

Limitations/Caveats

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.

More Information

Certain Agreements

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

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.