Trial Outcomes & Findings for A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections (NCT NCT00721578)
NCT ID: NCT00721578
Last Updated: 2011-01-10
Results Overview
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Recruitment status
COMPLETED
Target enrollment
23 participants
Primary outcome timeframe
Up to 9 months
Results posted on
2011-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
11
|
|
Overall Study
COMPLETED
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
Baseline Characteristics
A Study Of Indian Patients Receiving Therapy For Systemic Fungal Infections
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=23 Participants
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: 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
Evidence of clinical signs and symptoms of systemic fungal infection including: fever, hypotension, or radiological or microbiological evidence, as assessed by the investigator.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Diagnosis of Systemic Fungal Infection (SFI)
Fever
|
20 Participants
|
|
Diagnosis of Systemic Fungal Infection (SFI)
Hypotension
|
6 Participants
|
|
Diagnosis of Systemic Fungal Infection (SFI)
Radiological Assessment (SOT - Abnormal)
|
18 Participants
|
|
Diagnosis of Systemic Fungal Infection (SFI)
Radiological Assessment (EOT - Abnormal)
|
3 Participants
|
|
Diagnosis of Systemic Fungal Infection (SFI)
Microbiological Assessment (positive, n=7)
|
5 Participants
|
|
Diagnosis of Systemic Fungal Infection (SFI)
Microbiological Assessment (negative, n=7)
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
Number of participants treated with each antifungal therapy. Each participant may have recieved 1 or more treatments as deemed clinically necessary by the investigator.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Management of SFI: Choice of Treatment
Amphotericin B
|
2 Participants
|
|
Management of SFI: Choice of Treatment
Voriconazole
|
12 Participants
|
|
Management of SFI: Choice of Treatment
Fluconazole
|
11 Participants
|
|
Management of SFI: Choice of Treatment
Caspofungin acetate
|
3 Participants
|
|
Management of SFI: Choice of Treatment
Amphotericine B, liposome
|
3 Participants
|
|
Management of SFI: Choice of Treatment
Caspofungin
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: FAS. Data were not analyzed.
Number of participants with reason for investigator's selection of particular antifungal therapy.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: FAS. Data were not analyzed.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
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.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Number of Participants With Clinical Outcomes.
Cured
|
2 Participants
|
|
Number of Participants With Clinical Outcomes.
Improved
|
11 Participants
|
|
Number of Participants With Clinical Outcomes.
Stable
|
6 Participants
|
|
Number of Participants With Clinical Outcomes.
Deteriorated
|
4 Participants
|
PRIMARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
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.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Number of Participants With Mycological Outcomes
Persistence
|
3 Participants
|
|
Number of Participants With Mycological Outcomes
Eradication
|
8 Participants
|
|
Number of Participants With Mycological Outcomes
Unknown
|
11 Participants
|
|
Number of Participants With Mycological Outcomes
Not Recorded
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Concomitant Medications
Potassium
|
2 Participants
|
|
Concomitant Medications
Vitamin B12 (cyanocobalamin and derivatives)
|
1 Participants
|
|
Concomitant Medications
Acetorphan
|
1 Participants
|
|
Concomitant Medications
Acetylcysteine
|
3 Participants
|
|
Concomitant Medications
Acetylsalycilic acid
|
2 Participants
|
|
Concomitant Medications
Acetylsalicylic acid/clopidogrel
|
1 Participants
|
|
Concomitant Medications
Aciclovir
|
1 Participants
|
|
Concomitant Medications
Allopurinol
|
1 Participants
|
|
Concomitant Medications
Ambroxol
|
1 Participants
|
|
Concomitant Medications
Ambroxol Hydrochloride
|
1 Participants
|
|
Concomitant Medications
Amikacin
|
4 Participants
|
|
Concomitant Medications
Amiodarone Hydrochloride
|
2 Participants
|
|
Concomitant Medications
Amlodipine
|
1 Participants
|
|
Concomitant Medications
Atorvastatin
|
1 Participants
|
|
Concomitant Medications
Atracurium
|
1 Participants
|
|
Concomitant Medications
B-Komplex "Leciva"
|
1 Participants
|
|
Concomitant Medications
Breva
|
1 Participants
|
|
Concomitant Medications
Budesonide
|
2 Participants
|
|
Concomitant Medications
Carvedilol
|
1 Participants
|
|
Concomitant Medications
Cefazolin
|
1 Participants
|
|
Concomitant Medications
Cefepime
|
1 Participants
|
|
Concomitant Medications
Cefotaxime
|
1 Participants
|
|
Concomitant Medications
Cefotaxime/sulbactam
|
1 Participants
|
|
Concomitant Medications
Ciprofloxacin
|
1 Participants
|
|
Concomitant Medications
Clindamycin
|
2 Participants
|
|
Concomitant Medications
Clopidogrel
|
2 Participants
|
|
Concomitant Medications
Colistin mesilate sodium
|
2 Participants
|
|
Concomitant Medications
Cordalin/old form/
|
2 Participants
|
|
Concomitant Medications
Deflazacort
|
1 Participants
|
|
Concomitant Medications
Diltiazem hydrochloride
|
1 Participants
|
|
Concomitant Medications
Doripenem
|
1 Participants
|
|
Concomitant Medications
Doxofylline
|
1 Participants
|
|
Concomitant Medications
Enalapril maleate
|
1 Participants
|
|
Concomitant Medications
Enoxaparin
|
1 Participants
|
|
Concomitant Medications
Epoetin alfa
|
1 Participants
|
|
Concomitant Medications
Escitalopram
|
1 Participants
|
|
Concomitant Medications
Esomeprazole
|
2 Participants
|
|
Concomitant Medications
Esomeprazole magnesium
|
1 Participants
|
|
Concomitant Medications
Ethambutol
|
2 Participants
|
|
Concomitant Medications
Fludrocortisone
|
1 Participants
|
|
Concomitant Medications
Fluoxetine hydrochloride
|
1 Participants
|
|
Concomitant Medications
Folic acid
|
1 Participants
|
|
Concomitant Medications
Folinic acid
|
1 Participants
|
|
Concomitant Medications
Furosemide
|
2 Participants
|
|
Concomitant Medications
Granulocyte colony stimulating factor
|
1 Participants
|
|
Concomitant Medications
Haloperidol
|
2 Participants
|
|
Concomitant Medications
Heparin-fraction, sodium salt
|
6 Participants
|
|
Concomitant Medications
Hydrocortisone
|
1 Participants
|
|
Concomitant Medications
Hydrocortisone hydrogen succinate
|
4 Participants
|
|
Concomitant Medications
Imipenem
|
2 Participants
|
|
Concomitant Medications
Immunoglobulins
|
1 Participants
|
|
Concomitant Medications
Insulin glargine
|
1 Participants
|
|
Concomitant Medications
Isoniazid
|
1 Participants
|
|
Concomitant Medications
Lactulose
|
2 Participants
|
|
Concomitant Medications
Lekovit ca
|
2 Participants
|
|
Concomitant Medications
Levetiracetam
|
2 Participants
|
|
Concomitant Medications
Levocetirizine
|
1 Participants
|
|
Concomitant Medications
Levofloxacin
|
4 Participants
|
|
Concomitant Medications
Linezolid
|
4 Participants
|
|
Concomitant Medications
Meropenem
|
8 Participants
|
|
Concomitant Medications
Methylprednisolone
|
2 Participants
|
|
Concomitant Medications
Metoclopramide hydrochloride
|
3 Participants
|
|
Concomitant Medications
Metronidazole
|
5 Participants
|
|
Concomitant Medications
Moxifloxacin
|
1 Participants
|
|
Concomitant Medications
Mycophenolate mofetil
|
1 Participants
|
|
Concomitant Medications
Ofloxacin
|
1 Participants
|
|
Concomitant Medications
Ondansetron
|
4 Participants
|
|
Concomitant Medications
Pantoprazole
|
9 Participants
|
|
Concomitant Medications
Pantoprazole sodium
|
6 Participants
|
|
Concomitant Medications
Paracetamol
|
8 Participants
|
|
Concomitant Medications
Pazufloxacin
|
1 Participants
|
|
Concomitant Medications
Pheniramine maleate
|
1 Participants
|
|
Concomitant Medications
Phenobarbital
|
1 Participants
|
|
Concomitant Medications
Phenytoin sodium
|
2 Participants
|
|
Concomitant Medications
Pip/tazo
|
1 Participants
|
|
Concomitant Medications
Piperacillin
|
1 Participants
|
|
Concomitant Medications
Piperacillin/tazobactam
|
4 Participants
|
|
Concomitant Medications
Polybion
|
2 Participants
|
|
Concomitant Medications
Polymyxin B
|
2 Participants
|
|
Concomitant Medications
Polymyxin B sulfate
|
3 Participants
|
|
Concomitant Medications
Prednisolone
|
2 Participants
|
|
Concomitant Medications
Primaxin
|
1 Participants
|
|
Concomitant Medications
Propylthiouracil
|
1 Participants
|
|
Concomitant Medications
Prulifloxacin
|
1 Participants
|
|
Concomitant Medications
Pyridoxine
|
1 Participants
|
|
Concomitant Medications
Ramipril
|
2 Participants
|
|
Concomitant Medications
Ranolazine
|
1 Participants
|
|
Concomitant Medications
Ribolac
|
1 Participants
|
|
Concomitant Medications
Sertraline
|
2 Participants
|
|
Concomitant Medications
Simvastatin
|
1 Participants
|
|
Concomitant Medications
Solifenacin
|
1 Participants
|
|
Concomitant Medications
Sulperazon
|
5 Participants
|
|
Concomitant Medications
Teicoplanin
|
11 Participants
|
|
Concomitant Medications
Tienam
|
1 Participants
|
|
Concomitant Medications
Tramadol
|
3 Participants
|
|
Concomitant Medications
Valproic acid
|
1 Participants
|
|
Concomitant Medications
Vancomycin
|
1 Participants
|
|
Concomitant Medications
Vancomycin hydrochloride
|
1 Participants
|
|
Concomitant Medications
Vitamin B-complex
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Median Duration of Antifungal Therapy
All Antifungals
|
12.0 Days
Interval 4.0 to 127.0
|
|
Median Duration of Antifungal Therapy
Voriconazole
|
13.0 Days
Interval 5.0 to 127.0
|
SECONDARY outcome
Timeframe: Up to 9 monthsPopulation: FAS.
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.
Outcome measures
| Measure |
All Antifungal Therapies
n=23 Participants
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
|
|---|---|
|
Medication Administration
All Antifungals Intravenous
|
17 Participants
|
|
Medication Administration
All Antifungals Oral
|
11 Participants
|
|
Medication Administration
Voriconazole Intravenous
|
5 Participants
|
|
Medication Administration
Voriconazole Oral
|
6 Participants
|
Adverse Events
Therapy for Systemic Fungal Infections
Serious events: 5 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Therapy for Systemic Fungal Infections
n=23 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
4.3%
1/23
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.
|
|
General disorders
Multi-organ failure
|
13.0%
3/23
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.
|
|
Infections and infestations
Sepsis
|
4.3%
1/23
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.
|
|
Infections and infestations
Septic shock
|
8.7%
2/23
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.
|
|
Nervous system disorders
Coma
|
4.3%
1/23
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.
|
|
Nervous system disorders
Somnolence
|
4.3%
1/23
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.
|
|
Renal and urinary disorders
Azotaemia
|
4.3%
1/23
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.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
4.3%
1/23
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.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.3%
1/23
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.
|
Other adverse events
| Measure |
Therapy for Systemic Fungal Infections
n=23 participants at risk
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
|
|---|---|
|
Gastrointestinal disorders
Vomiting
|
4.3%
1/23
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.
|
|
Renal and urinary disorders
Urinary incontinence
|
4.3%
1/23
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.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
4.3%
1/23
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER