Phase 3
N=76
Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan
Pelvic Inflammatory Disease
Bottom Line
View on ClinicalTrials.gov: NCT00871494 ↗Enrolled (actual)
76
Serious AEs
4.0%
Results posted
Nov 2011
Primary outcome: Primary: Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) — 94.1; 94.1; 93.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Azithromycin (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Nov 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) |
94.1; 94.1; 93.5 | — |
| SECONDARY Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) |
92.2; 100; 100 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) |
77.4; 85.3; 83.9 | — |
| SECONDARY Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) |
85.7; 85.7; 89.5 | — |
Summary
Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.
Eligibility Criteria
Inclusion Criteria
Both of following symptoms should be observed.
- Lower abdominal pain and/or lower abdominal tenderness.
- Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).
Exclusion Criteria
Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).
Data sourced from ClinicalTrials.gov (NCT00871494). 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.