Trial record 2 of 3 for:    "Legionellosis"

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01784770
First received: February 4, 2013
Last updated: September 8, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Legionnaires' Disease
Legionella Pneumophila Infections
Drug: Azithromycin IV

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Research Of Effectiveness And Safety On Patients With Legionella Pneumophila Infections, Continuous Treatment With Azithromycin IV And Tab Utilized As The First Administrative Evaluation for Legionnaires' Disease (RESCUE-L)

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Number of Participants with Clinical Response of Cure at the Test-of-Cure (TOC) Visit [ Time Frame: 29 days ] [ Designated as safety issue: No ]
    The clinical response was assigned by the investigator. A clinical response of cure was defined as: Test article and the initial intervention (operative and/or radiologically controlled drainage procedure) resolved the intra-abdominal infection. Test-of-cure performed 10-28 days after last dose of study drug.


Estimated Enrollment: 20
Study Start Date: March 2013
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Azithromycin IV
Subjects who are treated with Azithromycin IV for Legionnaires' disease
Drug: Azithromycin IV

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.

Other Name: Zithromac IV

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who have been prescribed Zithromac or Zithromac SR.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01784770

Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01784770     History of Changes
Other Study ID Numbers: A0661208
Study First Received: February 4, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Legionnaires' disease
Legionella pneumophila
Zithromax
Zithromac
Japanese
Regulatory Post Marketing Commitment Plan

Additional relevant MeSH terms:
Infection
Communicable Diseases
Legionnaires' Disease
Legionellosis
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 16, 2014