Phase 3
N=16
POS vs FLU for First Line Treatment of Coccidioidomycosis (Study P04558Am1)(COMPLETED)
Coccidioidomycosis
Bottom Line
View on ClinicalTrials.gov: NCT00423267 ↗Enrolled (actual)
16
Serious AEs
3.6%
Results posted
Jun 2010
Primary outcome: Primary: Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A — 5; 3 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Posaconazole (Drug); Fluconazole (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) or Fluconazole (FLU) in Period A |
5; 3 | — |
| PRIMARY Number of Participants With Treatment-related Treatment-emergent Adverse Events (TRAEs) That Occurred With Posaconazole (POS) in Period B |
3 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs)That Occurred With POS or FLU in Period A |
8; 5 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) That Occurred With POS in Period B |
8 | — |
| SECONDARY Number of Participants With Laboratory Test Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS or FLU in Period A |
4; 1; 4; 3; 0; 1 | — |
| SECONDARY Number of Participants With Laboratory Abnormalities (at Least a 1 Grade Shift From Baseline) That Occurred With POS in Period B |
2; 11; 1; 0 | — |
| SECONDARY Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period A |
0; 0 | — |
| SECONDARY Number of Participant Discontinuations Due to Adverse Events and/or Laboratory Evaluations of Safety in Period B |
— | — |
Summary
To evaluate the safety of posaconazole (POS) in the treatment of coccidioidomycosis. Period A consisted of 2 blinded arms, posaconazole and fluconazole. Recruitment was stopped, and participants in Period A may have been eligible to roll over to an open-label, non-comparitive Period B. During Period B, participants received posaconazole for a treatment duration not to exceed 12 months.
Eligibility Criteria
Inclusion Criteria
- Thirteen years of age or older, 34 kg (75 lb) or more, either sex, and any race;
- Coccidioides immitis (C. immitis) or Coccidioides posadasii (C. posadasii) identified by culture or microscopic examination from skeletal disease, chronic active pulmonary disease, or soft tissue disease;
- Coccidioidomycosis score of >=6;
- Clinical laboratory safety tests within normal limits or clinically acceptable to the sponsor;
- Free of any clinically significant disease that would interfere with study evaluations;
- Willing to give written informed consent and able to adhere to study medication dose, mandatory procedures (including human immunodeficiency virus (HIV) testing), and visit schedules;
- Able to swallow food or a nutritional supplement;
- Use of a medically accepted method of contraception;
- Negative serum pregnancy test at Screening and negative urine pregnancy test at Randomization;
- Women of childbearing potential not currently sexually active must agree to use a medically accepted method of contraception should they become sexually active while participating in the study.
Exclusion Criteria
- Key Exclusion Criteria
Excluded Medications at Enrollment
- Medications that are known to interact with POS or FLU and that may lead to serious or life threatening side effects within 7 days prior to initiating study drug;
- Medications known to lower the serum concentration/efficacy of azole antifungals within 7 days prior to study drug start;
- Prior investigational drug use or biologic product administration within 30 days before study drug start;
- Prior antifungal treatment for the current episode of infection with a total cumulative dose of >=8 g of any azole, >=4 mg/kg of amphotericin B deoxycholate, or >=20 mg/kg of lipid amphotericin B;
- Antiretrovirals that are substrates of CYP3A4 administered to HIV-positive subjects, as it is not currently known how POS or FLU may affect such drugs or the potential to cause adverse reactions.
- Excluded Concomitant Conditions
- Immediately life-threatening coccidioidomycosis;
- Confirmed or suspected meningeal coccidioidomycosis;
- Pulmonary coccidioidomycosis in HIV-negative subjects for less than 3 months;
- Any condition requiring use of prohibited drugs;
- Cluster of Differentiation 4 (CD4) count of 5 times upper limit of normal (ULN)) or a total bilirubin level or direct bilirubin > 3 times ULN plus ALT or AST >2 times ULN (Hy's Rule);
- Moderate or severe renal dysfunction (creatinine clearance (CrCl) 450 msec for males and QTc >470 msec for females.
- General Exclusion Criteria
- Prior enrollment in this study or other POS studies;
- Failed treatment with FLU or POS at any time in the past;
- History of hypersensitivity or idiosyncratic reactions to azole drug therapy;
- Women who are pregnant, intend to become pregnant, or are breast-feeding;
- Situation or condition that may interfere with optimal participation in the study;
Part of the staff personnel directly involved with this study;
- Family member of the investigational study staff.
Data sourced from ClinicalTrials.gov (NCT00423267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.