Pelvic Inflammatory DiseasePhase 3NCT00871494

Study Of Azithromycin Intravenous Formulation Against Pelvic Inflammatory Disease (PID) In Japan

A Phase 3 study testing Azithromycin in people with Pelvic Inflammatory Disease, run by Pfizer at 31 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 16 to 80 years, women only
Conditions the study is for: Pelvic Inflammatory Disease
What is being tested?: Azithromycin
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 76 participants
Where: 31 sitesJapan
Study dates: May 2009to Nov 2010
Phase: Phase 3
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 16 to 80 years
Women only
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Both of following symptoms should be observed.
Lower abdominal pain and/or lower abdominal tenderness.
Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).

Who cannot join

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

Trial locations and contacts

31 sites in 1 country.

City, postcode or hospital

31 sites in 1 country

Japan31 sites

Pfizer Investigational Site
Aichi-gun, Aichi-ken
Pfizer Investigational Site
Aoba-ku, Sendai-city
Pfizer Investigational Site
Chuo-ku, Hyōgo
Pfizer Investigational Site
Chuou-ku, Fukuoka-city
Pfizer Investigational Site
Fukushima, Fukushima
Pfizer Investigational Site
Fukushima
Pfizer Investigational Site
Hakodate-shi Goryoukaku-cho, Hokkaido
Pfizer Investigational Site
Hakodate-shi Hon-cho, Hokkaido
Pfizer Investigational Site
Hirosaki, Aomori
Pfizer Investigational Site
Ichinomiya, Aichi-ken
Pfizer Investigational Site
Kagoshima, Kagoshima-ken
Pfizer Investigational Site
Kamigyou-ku, Kyoto-city
Pfizer Investigational Site
Kasuga, Fukuoka
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Kitakyushu-shi, Yahatanishi-ku, Fukuoka
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Koshigaya, Saitama
Pfizer Investigational Site
Kounoike Shinmachi, Kagoshima-city
Pfizer Investigational Site
Meguro-ku, Tokyo
Pfizer Investigational Site
Minato-ku, Tokyo
Pfizer Investigational Site
Nagano, Nagano
Pfizer Investigational Site
Nagoya-city Naka-ku, Aichi-ken
Pfizer Investigational Site
Nakaku, Yokohama-city Kanagawa
Pfizer Investigational Site
Niihama, Ehime
Pfizer Investigational Site
Okayama, Okayama-city
Pfizer Investigational Site
Okayama, Okayama-ken
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Suzaka-shi, Nagano
Pfizer Investigational Site
Takasaki, Gunma
Pfizer Investigational Site
Takasaki-shi, Gunma
Pfizer Investigational Site
Tanba-gun Fusou-chou, Aichi-ken

Other trials in Japan

About this study

Official title: A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy

Azithromycin had a potent in vitro activities and broad spectrum from typical and atypical bacteria to anaerobes. Azithromycin intravenous formulation demonstrated high efficacy and eradication rate in the western clinical trials. Development of azithromycin intravenous formulation would bring the clinical benefit to patients with pelvic inflammatory disease (PID) in Japan.

Conditions: Pelvic Inflammatory Disease
Being tested: Azithromycin
Medical subject headings: Pelvic Inflammatory Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AzithromycinDrug
The patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.

Study groups in NCT00871494
Study group	Role	What they receive
Azithromycin switch therapy (switch from intravenous to oral).	Experimental	Not described Receives: Drug: Azithromycin

What is being measured

The primary outcome is the main question the study is designed to answer.

Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Measured: End of Treatment, Day 15 and Day 29

Secondary outcomes (3)

Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Measured: End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication, presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Measured: End of treatment, Day 15, Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Eradication Rate was calculated from the following formula, "the number of participants assessed as eradication , presumed eradication and microbial substitution" over "total participants excluding ones assessed as indeterminate" multiplied by 100.
The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.
Measured: End of treatment, Day 15, Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2009Nov 2010

First posted30 Mar 2009 (estimated)
Study startMay 2009
Primary completionNov 2010
Study completionNov 2010

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pelvic Inflammatory DiseaseStudies 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: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 76 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00871494
Sponsor's protocol ID: A0661192
Status last verified: Sep 2011
First submitted: 27 Mar 2009
Last updated: 3 Nov 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014 Jul;20(7):429-35. doi: 10.1016/j.jiac.2014.04.001. Epub 2014 Apr 29.
PubMed 24787738

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection

All Pelvic Inflammatory Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Non-Randomized, Open Label Study Of Azithromycin Intravenous Followed By Oral Administration In Japanese Adult Subjects With Pelvic Inflammatory Disease (PID) Requiring Initial Intravenous Therapy
ClinicalTrials.gov ID: NCT00871494
Acronym / sponsor ID: A0661192
Conditions: Pelvic Inflammatory Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 76 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: May 2009
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 30 Mar 2009 (estimated)
Results: Posted 3 Nov 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Azithromycin switch therapy (switch from intravenous to oral).	Experimental	Drug: Azithromycin

Who may qualify

Ages: 16 to 80 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Both of following symptoms should be observed.
Lower abdominal pain and/or lower abdominal tenderness.
Hypochondrial pain and/or hypochondrial tenderness (tenderness of uterus or adnexa of uterus).

Key exclusion criteria (2 listed)

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.
Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

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
AzithromycinThe patients will receive 500 mg intravenous azithromycin QD for 1 to 2 days. The period of administration of intravenous dosing is judged by investigators according to patient status. Following intravenous administration, the patients will be received the 250 mg oral azithromycin (tablet formulation) QD to complete a total of 7 days therapy.	Drug	Azithromycin switch therapy (switch from intravenous to oral).

Primary outcome

Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time frame: End of Treatment, Day 15 and Day 29
Response rate was calculated from the following formula, "the number of participants assessed as effective" over "total participants excluding ones assessed as indeterminate" multiplied by 100. The inclusion criterion regarding fever was amended from the required criteria to the additional criteria in consultation with the regulatory authority. The subset of participants who were enrolled after the protocol amendment was the primary analysis sets for efficacy.

3 secondary outcomes

Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time frame: End of Treatment, Day 15 and Day 29
Eradication Rate (Bacteriological Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time frame: End of treatment, Day 15, Day 29
Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Time frame: End of treatment, Day 15, Day 29

Results and safety

Results posted to the registry on 3 Nov 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Azithromycin	76	62

Primary outcome: Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)

Time frame: End of Treatment, Day 15 and Day 29. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Azithromycin n = 51
End of Treatment (n=51)	94.1 (83.8 to 98.8)
Day 15 (n=51)	94.1 (83.8 to 98.8)
Day 29 (n=46)	93.5 (82.1 to 98.6)

Population analysed: Clinical per protocol set consisted of all participants who received at least one dose, had no significant violation of protocol, and underwent prescribed evaluations during the observation period. No imputation was used for missing data. "n" in the Measure Categories means total participants excluding ones assessed as indeterminate.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Azithromycin	3 of 76 (3.9%)	35 of 76 (46.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24787738Mikamo H, Iwasaku K, Yamagishi Y, Matsumizu M, Nagashima M. Efficacy and safety of intravenous azithromycin followed by oral azithromycin for the treatment of acute pelvic inflammatory disease and perihepatitis in Japanese women. J Infect Chemother. 2014 Jul;20(7):429-35. doi: 10.1016/j.jiac.2014.04.001. Epub 2014 Apr 29.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

Related trials for Pelvic Inflammatory Disease

Not yet recruitingPhase 4
ASAPP Study - Topical 5-ASA as Prophylaxis for Pouchitis in Ulcerative Colitis Patients After Pelvic Pouch Surgery
Ulcerative Colitis (UC), Pouchitis
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Recruiting
Comparison of Proton or Intensity Modulated Radiation Therapy After Surgery for Endometrial or Cervical Cancer
Cervical Carcinoma, Endometrial Carcinoma
RecruitingPhase 1/2
Assessing the Mechanisms and Impact of a Novel Cannabinoid Product for Gynecologic Pain
Endometriosis, Adenomyosis
Not yet recruiting
Effect of Betadine Vaginal Cleansing Before Cesarean Section to Reduce Postoperative Infectious Morbidity
Cesarean Section, Surgical Site Infection

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

31 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Azithromycin in people with Pelvic Inflammatory Disease, run by Pfizer at 31 sites in Japan.

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 3 inclusion and 2 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 3 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Nov 2011). 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?

Response Rate (Clinical Response, Data Review Committee Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) (time frame: End of Treatment, Day 15 and Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00871494, which also lists 1 linked publication.

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 3 Nov 2011.