Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pelvic Inflammatory Disease

Treatments: Drug: Azithromycin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00871494

A0661192

Details and patient eligibility

About

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.

Enrollment: 76 patients

Sex: Female

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Azithromycin switch therapy (switch from intravenous to oral).

Experimental group

Treatment:

Drug: Azithromycin