N/A N=502

Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

Bacterial Infections

Bottom Line

View on ClinicalTrials.gov: NCT00998309 ↗

Enrolled (actual)

502

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. — 438; 19 participants

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: Azithromycin SR (Drug)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Pfizer
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.	438; 19	—
PRIMARY Number of Participants With Treatment Related Adverse Events (TRAEs)	446; 52	—
PRIMARY Number of Unlisted Treatment Related Adverse Events (TRAEs)	61; 2	—
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender	272; 185; 254; 184	=0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age	414; 43; 396; 42	=1.000
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection	96; 199; 162; 95; 181; 162	<0.001 sig
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity	152; 260; 45; 147; 247; 44	=0.556
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)	395; 2; 381; 1	=0.074
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)	397; 1; 382; 1	=1.000
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)	441; 16; 422; 16	=1.000
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications	408; 49; 391; 47	=1.000
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)	441; 16; 422; 16	=1.000
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)	284; 173; 274; 164	=0.470
SECONDARY Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy	423; 34; 405; 33	=1.000
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender	287; 211; 32; 20	=0.657
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age	448; 50; 50; 2	=0.145
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection	104; 199; 183; 2; 24; 26	=0.005 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity	168; 283; 47; 19; 25; 8	=0.213
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction	422; 2; 48; 0	=1.000
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction	423; 1; 48; 1	=0.116
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History	481; 17; 42; 10	<0.001 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications	441; 57; 45; 7	=0.645
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)	481; 16; 50; 2	=0.679
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs	298; 200; 27; 25	=0.234
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy	463; 35; 52; 0	=0.039 sig
SECONDARY Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female	199; 11; 20; 0	=0.605

Summary

To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.

Eligibility Criteria

Inclusion Criteria

Male or female subjects diagnosed with skin and soft tissue infection, sexually-transmitted infection, and infection of the oral.
Subjects must have no prior experience with Azithromycin SR.

Exclusion Criteria

Patients not administered Azithromycin SR.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00998309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.