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

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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)

76 participants in 1 patient group

Azithromycin switch therapy (switch from intravenous to oral).
Experimental group
Treatment:
Drug: Azithromycin

Trial contacts and locations

31

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Data sourced from clinicaltrials.gov

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