NCT00809328

Brief Summary

Azithromycin has high rates of clinical response and eradication, wide spectrum of activity, so we suppose the development of the azithromycin injectable formulation in Japan would deliver benefit to patients of community acquired pneumonia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Feb 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

34 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 13, 2011

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

1.1 years

First QC Date

December 16, 2008

Results QC Date

March 22, 2011

Last Update Submit

May 16, 2011

Conditions

Community Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

  • Response Rate (Clinical Response, Data Review Committee Assessment)

    Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.

    End of Treatment, Day 15 and Day 29

Secondary Outcomes (4)

  • Response Rate (Clinical Response, Investigator Assessment)

    End of Treatment, Day 15 and Day 29

  • The Tendency Toward Clinical Improvement (Investigator Assessment)

    Day 3

  • Eradication Rate (Bacteriological Response, Data Review Committee Assessment)

    Day 3, End of Treatment, Day 15 and Day 29

  • Eradication Rate (Bacteriological Response, Investigator Assessment)

    Day 3, End of Treatment, Day 15 and Day 29

Study Arms (1)

Azithromycin

EXPERIMENTAL

Azithromycin switch therapy (switch from intravenous to oral)

Drug: Azithromycin

Interventions

AzithromycinDRUG

The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.

Azithromycin

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years of age or older patients with CAP.
  • Patients who were diagnosed as moderate in severity.

You may not qualify if:

  • Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
  • Hepatic dysfunction (AST, ALT, total bilirubin \> 3 times institutional normal).
  • Severe renal dysfunction (creatinine clearance \< 30 ml/min).
  • Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients who have a congenital or sporadic long QT syndrome, or who are received the drugs with reported QT prolongation.
  • Severe underlying disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (34)

Pfizer Investigational Site

Seto-shi, Aichi-ken, Japan

Location

Pfizer Investigational Site

Touon, Ehime, Japan

Location

Pfizer Investigational Site

Chikushino-shi, Fukuoka, Japan

Location

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Location

Pfizer Investigational Site

Koga, Fukuoka, Japan

Location

Pfizer Investigational Site

Yanagawa, Fukuoka, Japan

Location

Pfizer Investigational Site

Higashihiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Location

Pfizer Investigational Site

Asahikawa, Hokkaido, Japan

Location

Pfizer Investigational Site

Himejishi, Hyōgo, Japan

Location

Pfizer Investigational Site

Moriya, Ibaraki, Japan

Location

Pfizer Investigational Site

Kanazawa, Ishikawa-ken, Japan

Location

Pfizer Investigational Site

Takamatsu, Kagawa-ken, Japan

Location

Pfizer Investigational Site

Kawasaki, Kanagawa, Japan

Location

Pfizer Investigational Site

Kochi, Kochi, Japan

Location

Pfizer Investigational Site

Tsu, Mie-ken, Japan

Location

Pfizer Investigational Site

Sendai, Miyagi, Japan

Location

Pfizer Investigational Site

Matsumoto, Nagano, Japan

Location

Pfizer Investigational Site

Emukae, Kitamatsuura, Nagasaki, Japan

Location

Pfizer Investigational Site

Isahaya, Nagasaki, Japan

Location

Pfizer Investigational Site

Nagasaki, Nagasaki, Japan

Location

Pfizer Investigational Site

Sasebo, Nagasaki, Japan

Location

Pfizer Investigational Site

Niigata, Niigata, Japan

Location

Pfizer Investigational Site

Ōita, Oita Prefecture, Japan

Location

Pfizer Investigational Site

Yufu, Oita Prefecture, Japan

Location

Pfizer Investigational Site

Kurashiki, Okayama-ken, Japan

Location

Pfizer Investigational Site

Okinawa, Okinawa, Japan

Location

Pfizer Investigational Site

Sakai, Osaka, Japan

Location

Pfizer Investigational Site

Ureshinoshi, Saga-ken, Japan

Location

Pfizer Investigational Site

Hamamatsu, Shizuoka, Japan

Location

Pfizer Investigational Site

Meguro-Ku, Tokyo, Japan

Location

Pfizer Investigational Site

Toshima-ku, Tokyo, Japan

Location

Pfizer Investigational Site

Yonezawa, Yamagata, Japan

Location

Pfizer Investigational Site

Shiogama, Japan

Location

Related Publications (1)

  • Kohno S, Tateda K, Kadota J, Fujita J, Niki Y, Watanabe A, Nagashima M. Contradiction between in vitro and clinical outcome: intravenous followed by oral azithromycin therapy demonstrated clinical efficacy in macrolide-resistant pneumococcal pneumonia. J Infect Chemother. 2014 Mar;20(3):199-207. doi: 10.1016/j.jiac.2013.10.010. Epub 2013 Dec 11.

    PMID: 24477328DERIVED

Related Links

MeSH Terms

Conditions

Community-Acquired Pneumonia

Interventions

Azithromycin

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

ErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Results Point of Contact

Title
Pfizer ClinicalTrials.gov Call Center
Organization
Pfizer, Inc.
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

February 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 19, 2011

Results First Posted

April 13, 2011

Record last verified: 2011-05

Locations

JP(34)