Special Investigation Of Azithromycin IV For Legionnaires' Disease (Regulatory Post Marketing Commitment Plan)

NCT01784770 | Completed Results

• 1 other identifier: A0661208
• Study Type: observational
• Target: 21
• Locations: 0 countries
• Sites: N/A

Brief Summary

To collect retrospectively the efficacy and safety information of azithromycin IV on patients with Legionnaires' disease related to their appropriate use in daily practice.

Conditions

Legionnaires' Disease; Legionella Pneumophila Infections

Keywords

Legionnaires' disease; Legionella pneumophila; Zithromax; Zithromac; Japanese; Regulatory Post Marketing Commitment Plan

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Treatment-Related Adverse Events

  A treatment-related adverse event was any untoward medical occurrence attributed to Zithromac Intravenous use (and Zithromac Tablets) in a participant who received Zithromac Intravenous use. A treatment-related serious adverse event was a treatment-related adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Relatedness to Zithromac Intravenous use (and Zithromac Tablets) was assessed by the physician.

  29 days

Secondary Outcomes (1)

• Clinical Effectiveness Rate in Participants

  29 days

Study Arms (1)

Azithromycin IV

Subjects who are treated with Azithromycin IV for Legionnaires' disease

Drug: Azithromycin IV

Interventions

Azithromycin IV DRUG

The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy. The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy.

Also known as: Zithromac IV

Azithromycin IV

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The patients whom an investigator involving A0661208 prescribes the Zithromac IV.

You may qualify if:

• All patients who are prescribed Azithromycin (Zithromac) IV for Legionnaires' disease.

You may not qualify if:

• Patients who have been prescribed Zithromac or Zithromac SR.

Sponsors & Collaborators

• Pfizer: lead

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Legionnaires' Disease

Condition Hierarchy (Ancestors)

Legionellosis; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Respiratory Tract Diseases

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: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2013
• First Posted: February 6, 2013
• Study Start: March 27, 2013
• Primary Completion: July 29, 2016
• Study Completion: July 29, 2016
• Last Updated: November 30, 2017
• Results First Posted: November 30, 2017

Record last verified: 2017-07