RESCUE: Drug Use Investigation Of Azithromycin IV For Pneumonia Or Pelvic Inflammatory Disease (Regulatory Post Marketing Commitment Plan)

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01671280
• Collaborator: (none)
• Enrollment: 403
• Actual Duration (Months): 43

Study Details

Study Description

Brief Summary

To collect the efficacy and safety information of Azithromycin IV related to their appropriate use in daily practice

Condition or Disease	Intervention/Treatment	Phase
Pneumonia; Pelvic Inflammatory Disease	Drug: Azithromycin IV

Study Design

• Study Type: Observational
• Actual Enrollment: 403 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Drug Use Investigation Of Azithromycin Iv
• Actual Study Start Date: Sep 20, 2012
• Actual Primary Completion Date: Apr 22, 2016
• Actual Study Completion Date: Apr 22, 2016

Arms and Interventions

Arm

Intervention/Treatment

Azithromycin IV Subjects who are treated with Azithromycin IV

Drug: Azithromycin IV; The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with 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 Names: Zithromac IV

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Treatment-Related Adverse Events [29 days]

   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 (and Zithromac Tablets). 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.

Secondary Outcome Measures

1. Clinical Effectiveness Rate in Participants With Pneumonia [29 days]

   Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.

2. Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease [29 days]

   Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male or Female patients who are prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Exclusion Criteria:

• Subjects who have been prescribed Zithromac IV for pneumonia or pelvic inflammatory disease.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT01671280
• Other Study ID Numbers: A0661207
• First Posted: Aug 23, 2012
• Last Update Posted: Apr 26, 2017
• Last Verified: Mar 1, 2017

• Keywords provided by Pfizer: pneumonia; pelvic inflammatory disease; Zithromax; Zithromac; Japanese; Regulatory Post Marketing Commitment Plan
• Additional relevant MeSH terms: Pneumonia; Pelvic Inflammatory Disease; Pelvic Infection; Azithromycin

Study Results

Participant Flow

Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
Period Title: Overall Study
STARTED	403
COMPLETED	401
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
Overall Participants	400
Age, Customized (Number) [Number]
<15 years	1 0.3%
≥15 and <65 years	191 47.8%
≥65 years	208 52%
Sex: Female, Male (Count of Participants)
Female	206 51.5%
Male	194 48.5%
Disease Type (participants) [Number]
Pneumonia*	299 74.8%
Pelvic inflammatory disease*	98 24.5%
Other*	6 1.5%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Treatment-Related Adverse Events
Description	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 (and Zithromac Tablets). 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.
Time Frame	29 days

Outcome Measure Data

Analysis Population Description

The safety analysis set comprised of participants who satisfied the inclusion criteria and received Zithromac Intravenous use at least once.

Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
Measure Participants	400
Treatment-Related Adverse Event	39 9.8%
Treatment-Related Serious Adverse Event	7 1.8%

2. Secondary Outcome

Title	Clinical Effectiveness Rate in Participants With Pneumonia
Description	Clinical effectiveness rate in participants with pneumonia, which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with pneumonia, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.
Time Frame	29 days

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of pneumonia (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
Measure Participants	259
Number (95% Confidence Interval) [Percentage of Participants]	89.6 22.4%

3. Secondary Outcome

Title	Clinical Effectiveness Rate in Participants With Pelvic Inflammatory Disease
Description	Clinical effectiveness rate in pelvic inflammatory disease (PID), which was defined as the percentage of participants who achieved clinical effectiveness over the total number of asssable effectiveness analysis population with PID, was presented along with the corresponding 2-sided 95% CI. Clinical effectiveness of Zithromac Intravenous use (and Zithromac Tablets) was determined by the physician based on clinical symptoms and laboratory findings, and assessed according to the following categories: (1) effective, (2) ineffective, or (3) unassessable.
Time Frame	29 days

Outcome Measure Data

Analysis Population Description

The effectiveness analysis set comprised of participants in the safety analysis set who had effectiveness evaluation of PID (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Participants evaluated as "unassessable" were excluded from the calculation.

Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
Measure Participants	91
Number (95% Confidence Interval) [Percentage of Participants]	91.2 22.8%

Adverse Events

Adverse Event Reporting Description	The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Zithromac Intravenous Use (Azithromycin Hydrate)
Arm/Group Description	Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician's discretion.
All Cause Mortality
	Zithromac Intravenous Use (Azithromycin Hydrate)
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Zithromac Intravenous Use (Azithromycin Hydrate)
	Affected / at Risk (%)	# Events
Total	43/400 (10.8%)
Blood and lymphatic system disorders
Iron deficiency anaemia	1/400 (0.3%)
Disseminated intravascular coagulation	2/400 (0.5%)
Anaemia	1/400 (0.3%)
Cardiac disorders
Cardiac failure congestive	1/400 (0.3%)
Cardiac failure	2/400 (0.5%)
Cardiac failure chronic	3/400 (0.8%)
Gastrointestinal disorders
Diarrhoea	2/400 (0.5%)
Duodenal ulcer	1/400 (0.3%)
Gastritis haemorrhagic	1/400 (0.3%)
Duodenal ulcer haemorrhage	1/400 (0.3%)
Upper gastrointestinal haemorrhage	1/400 (0.3%)
Infections and infestations
Clostridium difficile colitis	1/400 (0.3%)
Gastroenteritis staphylococcal	1/400 (0.3%)
Pneumonia bacterial	1/400 (0.3%)
Urinary tract infection	1/400 (0.3%)
Sepsis	1/400 (0.3%)
Pneumonia	12/400 (3%)
Peritonitis	1/400 (0.3%)
Injury, poisoning and procedural complications
Toxicity to various agents	1/400 (0.3%)
Metabolism and nutrition disorders
Hyperkalaemia	1/400 (0.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant	1/400 (0.3%)
Nervous system disorders
Cerebral infarction	1/400 (0.3%)
Pregnancy, puerperium and perinatal conditions
Abortion complete	1/400 (0.3%)
Renal and urinary disorders
Renal impairment	1/400 (0.3%)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease	6/400 (1.5%)
Organising pneumonia	1/400 (0.3%)
Acute respiratory distress syndrome	1/400 (0.3%)
Dyspnoea	1/400 (0.3%)
Respiratory failure	1/400 (0.3%)
Hypercapnia	1/400 (0.3%)
Idiopathic pulmonary fibrosis	1/400 (0.3%)
Bronchitis chronic	1/400 (0.3%)
Vascular disorders
Circulatory collapse	1/400 (0.3%)
Deep vein thrombosis	1/400 (0.3%)
Other (Not Including Serious) Adverse Events
	Zithromac Intravenous Use (Azithromycin Hydrate)
	Affected / at Risk (%)	# Events
Total	34/400 (8.5%)
Gastrointestinal disorders
Diarrhoea	14/400 (3.5%)
Hepatobiliary disorders
Hepatic function abnormal	9/400 (2.3%)
Liver disorder	5/400 (1.3%)
Psychiatric disorders
Insomnia	6/400 (1.5%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.