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A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Mild to Moderate Pneumonia in Adult Patients

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT00643734
Collaborator
(none)
468
Enrollment
65
Locations
2
Arms
12
Duration (Months)
7.2
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study was performed to see if a single, 2.0-g oral dose of azithromycin sustained release (SR) was at least as effective as a 7-day regimen of levofloxacin (500 mg once daily) for the treatment of mild to moderate community-acquired pneumonia, and to assess the efficacy and safety of both treatment regimens.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
468 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Levofloxacin for the Treatment of Mild to Moderate Community-Acquired Pneumonia in Adults
Study Start Date :
Apr 1, 2003
Actual Study Completion Date :
Apr 1, 2004

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

Drug: azithromycin sustained release
azithromycin SR 2.0 g by mouth in the form of a slurry for 1 dose

Other: placebo
placebo
Experimental: 2

Drug: levofloxacin
500 mg (two 250 mg capsules) by mouth once daily for 7 days

Other: placebo
placebo

Outcome Measures

Primary Outcome Measures

  1. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [Test of Cure (TOC) visit (Days 14-21)]

Secondary Outcome Measures

  1. laboratory abnormalities [Baseline and TOC visit]

  2. sponsor assessment of clinical response (cure or failure) in the remaining study populations [EOT visit and TOC visit]

  3. sponsor assessment of clinical response by baseline pathogen for the Bacteriological Per Protocol population [EOT visit and TOC visit]

  4. investigator assessment of clinical response (cure or failure) in the Clinical Per Protocol population [TOC visit]

  5. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [End of Treatment (EOT) visit (Days 8-11)]

  6. bacteriological response on a per pathogen basis for the Bacteriological Per Protocol population [TOC visit]

  7. sponsor assessment of clinical response (cure or failure) in the Clinical Per Protocol population [Long-Term Follow-Up (LTFU) visit (Days 28-35)]

  8. summary of baseline susceptibilities [Study endpoint]

  9. adverse events [Continuous]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

Patients with clinical evidence of mild to moderate community-acquired pneumonia, including cough productive of sputum and a diagnosis of pneumonia, were included.

Exclusion Criteria:

Key exclusion criteria were treatment with any systemic antibiotic of greater than one dose or one combination dose within the previous 7 days, previously diagnosed conditions which tend to mimic or complicate the course and the evaluation of the evaluation process (e.g., bronchiectasis, lung abscess or empyema, active tuberculosis, pulmonary malignancy, cystic fibrosis, post-obstructive pneumonia), hospitalization in the previous 14 days or infection acquired in the hospital, and residents of a long-term care facility.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pfizer Investigational Site Mesa Arizona United States 85206
2 Pfizer Investigational Site Phoenix Arizona United States 85014
3 Pfizer Investigational Site San Luis Obispo California United States 93401
4 Pfizer Investigational Site San Mateo California United States 94403
5 Pfizer Investigational Site Highlands Ranch Colorado United States 80130
6 Pfizer Investigational Site Newark Delaware United States 19702
7 Pfizer Investigational Site Kissimmee Florida United States 34741
8 Pfizer Investigational Site Merrit Island Florida United States 32953
9 Pfizer Investigational Site Evansville Indiana United States 47712
10 Pfizer Investigational Site Evansville Indiana United States 47714
11 Pfizer Investigational Site Indianapolis Indiana United States 46254
12 Pfizer Investigational Site Dubuque Iowa United States 52001
13 Pfizer Investigational Site Pratt Kansas United States 67124
14 Pfizer Investigational Site Madisonville Kentucky United States 42431
15 Pfizer Investigational Site Cumberland Maryland United States 21502
16 Pfizer Investigational Site Kalamazoo Michigan United States 49009
17 Pfizer Investigational Site Olive Branch Mississippi United States 38654
18 Pfizer Investigational Site Elkhorn Nebraska United States 68022
19 Pfizer Investigational Site Omaha Nebraska United States 68144
20 Pfizer Investigational Site Rio Rancho New Mexico United States 87124
21 Pfizer Investigational Site Charlotte North Carolina United States 28209
22 Pfizer Investigational Site Charlotte North Carolina United States 28210
23 Pfizer Investigational Site Charlotte North Carolina United States 28262
24 Pfizer Investigational Site Hickory North Carolina United States 28601
25 Pfizer Investigational Site Yukon Oklahoma United States 73099
26 Pfizer Investigational Site Downingtown Pennsylvania United States 19335
27 Pfizer Investigational Site King of Prussia Pennsylvania United States 19406
28 Pfizer Investigational Site Morrisville Pennsylvania United States 19067
29 Pfizer Investigational Site Greer South Carolina United States 29651
30 Pfizer Investigational Site Dyersburg Tennessee United States 38024
31 Pfizer Investigational Site Lake Jackson Texas United States 77566
32 Pfizer Investigational Site Salt Lake City Utah United States 84109
33 Pfizer Investigational Site Salt Lake City Utah United States 84121
34 Pfizer Investigational Site Walla Walla Washington United States 99362
35 Pfizer Investigational Site Menomonee Falls Wisconsin United States 53051
36 Pfizer Investigational Site Langley British Columbia Canada V3A 4H9
37 Pfizer Investigational Site Hawkesbury Ontario Canada K6A 1A1
38 Pfizer Investigational Site Kitchener Ontario Canada N2C 2N9
39 Pfizer Investigational Site Toronto Ontario Canada M9W 4L6
40 Pfizer Investigational Site Montreal Quebec Canada H3H 1V4
41 Pfizer Investigational Site Pointe-Claire Quebec Canada H9R 4S3
42 Pfizer Investigational Site Ste-foy Quebec Canada G1V 4P9
43 Pfizer Investigational Site Victoriaville Quebec Canada G6P 6N2
44 Pfizer Investigational Site North Battleford Saskatchewan Canada S9A 0V6
45 Pfizer Investigational Site Saskatoon Saskatchewan Canada S7K 7H9
46 Pfizer Investigational Site Providencia Santiago Chile
47 Pfizer Investigational Site Bangalore Karnataka India 560052
48 Pfizer Investigational Site Bangalore Karnataka India 560054
49 Pfizer Investigational Site Indore Madhya Pradesh India
50 Pfizer Investigational Site Mumbai Maharashtra India 400 012
51 Pfizer Investigational Site Nagpur Maharashtra India
52 Pfizer Investigational Site Chennai Tamilnadu India 600116
53 Pfizer Investigational Site Vellore Tamilnadu India 632002
54 Pfizer Investigational Site Alytus Lithuania LT-4580
55 Pfizer Investigational Site Kaunas Lithuania LT-3021
56 Pfizer Investigational Site Klaipeda Lithuania LT-5800
57 Pfizer Investigational Site Monterrey Nuevo León Mexico 64460
58 Pfizer Investigational Site San Isidro Lima Peru
59 Pfizer Investigational Site San Miguel Lima Peru
60 Pfizer Investigational Site Moscow Russian Federation 105077
61 Pfizer Investigational Site Moscow Russian Federation 105229
62 Pfizer Investigational Site Moscow Russian Federation 107066
63 Pfizer Investigational Site Moscow Russian Federation 119048
64 Pfizer Investigational Site Moscow Russian Federation
65 Pfizer Investigational Site Smolensk Russian Federation 214019

Sponsors and Collaborators

  • Pfizer

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00643734
Other Study ID Numbers:
  • A0661103
First Posted:
Mar 26, 2008
Last Update Posted:
Mar 26, 2008
Last Verified:
Mar 1, 2008
Additional relevant MeSH terms:
Pneumonia
Azithromycin
Levofloxacin
Ofloxacin

Study Results

No Results Posted as of Mar 26, 2008