Bacterial InfectionsNCT00998309
Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)
An observational study of Bacterial Infections, run by Pfizer.
Trial summary
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Azithromycin SR
- How many people
- 502 participants
- Where
- No sites listed yet
- Study dates
- Oct 2009to Jan 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The patients whom an involving A0661202 prescribes the Azithromycin SR.
Who may be able to join
- 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.
Who cannot join
- Patients not administered Azithromycin SR.
About this study
Official title: Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
Read the detailed description
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
- Conditions
- Bacterial Infections
- Being tested
- Azithromycin SR
- Keywords
- skin infection, soft tissue infection, sexually-transmitted infection, infection oral, Regulatory Post Marketing Commitment Plan
- Medical subject headings
- Bacterial Infections, Cellulitis, Soft Tissue Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azithromycin SRDrug
Also called Zithromax SR, Azithromycin SR
Zithromax SR 2g, taking once for treatment.
| Study group | Role | What they receive |
|---|---|---|
| Azithromycin SR | Patients taking Azithromycin. Receives: Drug: Azithromycin SR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.
Measured: Baseline to 29 days
Number of Participants With Treatment Related Adverse Events (TRAEs)
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Measured: Baseline to 29 days
Number of Unlisted Treatment Related Adverse Events (TRAEs)
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
Measured: Baseline to 29 days
Secondary outcomes (23)
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender
Number of participants with responders of azithromycin to determine whether male or female is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age
Number of participants with responders of azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection
Number of participants with responders of azithromycin to determine whether type of infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental and Oral Surgery Infection", is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity
Number of participants with responders of azithromycin to determine whether Infection severity, "mild infection, moderate infection, or severe infection", is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)
Number of participants with responders of azithromycin to determine whether with or without hepatic dysfunction is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)
Number of participants with responders of azithromycin to determine whether with or without renal dysfunction is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)
Number of participants with responders of azithromycin to determine whether with or without past medical history is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications
Number of participants with responders of azithromycin to determine whether with or without complications is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)
Number of participants with responders of azithromycin to determine whether with or without previous antibiotic treatment history is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)
Number of participants with responders of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy
Number of participants with responders of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether male or female is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether <65 years or >=65 years is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether Type of Infection, "Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infection", is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether mild infection, moderate infection, or severe infection is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Hepatic Dysfunction is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Renal Dysfunction is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Past Medical History is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without complications is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without previous antibioutic treatment history (PATH) is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without comcomittant drugs is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without non-drug therapy is significant risk factor.
Measured: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female
Number of participants with Treatment Related Adverse Events (TRAEs) of azithromycin to determine whether with or without Pregnancy in Female is significant risk factor.
Measured: Baseline to 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 502 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998309
- Sponsor's protocol ID
- A0661202
- Status last verified
- Apr 2012
- First submitted
- 16 Oct 2009
- Last updated
- 1 May 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Zithromax-SR 2g, Special Investigation For Skin And Soft Tissue Infection, Sexually-Transmitted Infection, And Infection Of The Oral (Regulatory Post Marketing Commitment Plan)
- ClinicalTrials.gov ID
- NCT00998309
- Acronym / sponsor ID
- A0661202
- Conditions
- Bacterial Infections
- Keywords
- skin infection, soft tissue infection, sexually-transmitted infection, infection oral, Regulatory Post Marketing Commitment Plan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 502 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 20 Oct 2009 (estimated)
- Results
- Posted 1 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To collect the efficacy and safety information of Zithromax-SR related to their appropriate use in daily practice.
Detailed description
All the patients whom an investigator prescribes the first Azithromycin SR should be registered within 14 days.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Azithromycin SR | – | Drug: Azithromycin SRPatients taking Azithromycin. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The patients whom an involving A0661202 prescribes the Azithromycin SR.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not administered Azithromycin SR.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin SRAlso: Zithromax SR, Azithromycin SRZithromax SR 2g, taking once for treatment. | Drug | Azithromycin SR |
Primary outcome
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.
Time frame: Baseline to 29 days
The physician in charge of the survey performed comprehensive clinical effect evaluation on result of clinical findings, bacteriological effect and others. Clinical effect (Effective (cured)/ Not effective (not cured)/ unable to evaluate effectiveness evaluation) was performed at visits during the observation period by comparing to the data before administration of this drug.Criteria of cured was disappearance or improvement of clinical findings with infections and/or causal bacterial disappearance.
Number of Participants With Treatment Related Adverse Events (TRAEs)
Time frame: Baseline to 29 days
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
Number of Unlisted Treatment Related Adverse Events (TRAEs)
Time frame: Baseline to 29 days
All observed or volunteered adverse events and the investigator's opinion of the causal relationship to the study treatment were reported. Defenition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product. Unlisted treatment related adverse events were confirmed with listed adverse drug reaction in Japanese package insert.
23 secondary outcomes
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)
Time frame: Baseline to 29 days
Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy
Time frame: Baseline to 29 days
Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female
Time frame: Baseline to 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Bacterial Infections, run by Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With an Investigator's Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study. (time frame: Baseline to 29 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2012.