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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00871494
• Collaborator: (none)
• Enrollment: 76
• Locations: 31
• Arm: 1
• Duration (Months): 18
• Patients Per Site: 2.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Inflammatory Disease	Drug: Azithromycin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Study Start Date: May 1, 2009
• Actual Primary Completion Date: Nov 1, 2010
• Actual Study Completion Date: Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Azithromycin switch therapy (switch from intravenous to oral).	Drug: Azithromycin; 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.

Outcome Measures

Primary Outcome Measures

1. 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) [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.

Secondary Outcome Measures

1. Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) [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.

2. 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) [End of treatment, Day 15, Day 29]

   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.

3. Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option) [End of treatment, Day 15, Day 29]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 80 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

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).

Exclusion Criteria:

Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides, or ketolides.

Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Nagoya-city Naka-ku	Aichi-prefecture	Japan
2	Pfizer Investigational Site	Tanba-gun Fusou-chou	Aichi-prefecture	Japan
3	Pfizer Investigational Site	Aichi-gun	Aichi	Japan
4	Pfizer Investigational Site	Ichinomiya	Aichi	Japan
5	Pfizer Investigational Site	Hirosaki-city	Aomori-prefecture	Japan
6	Pfizer Investigational Site	Niihama-city	Ehime	Japan
7	Pfizer Investigational Site	Niihama	Ehime	Japan
8	Pfizer Investigational Site	Chuou-ku	Fukuoka-city	Japan
9	Pfizer Investigational Site	Kitakyushu-shi, Yahatanishi-ku	Fukuoka-ken	Japan
10	Pfizer Investigational Site	Kasuga-city	Fukuoka-prefecture	Japan
11	Pfizer Investigational Site	Kitakyusyu	Fukuoka	Japan
12	Pfizer Investigational Site	Takasaki-shi	Gunma-ken	Japan
13	Pfizer Investigational Site	Takasaki-city	Gunma-prefecture	Japan
14	Pfizer Investigational Site	Hakodate-shi Goryoukaku-cho	Hokkaido	Japan
15	Pfizer Investigational Site	Hakodate-shi Hon-cho	Hokkaido	Japan
16	Pfizer Investigational Site	Sapporo-shi	Hokkaido	Japan
17	Pfizer Investigational Site	Chuo-ku	Hyogo	Japan
18	Pfizer Investigational Site	Kobe	Hyogo	Japan
19	Pfizer Investigational Site	Kounoike shinmachi	Kagoshima-city	Japan
20	Pfizer Investigational Site	Kamigyou-ku	Kyoto-city	Japan
21	Pfizer Investigational Site	Suzaka-shi	Nagano-ken	Japan
22	Pfizer Investigational Site	Okayama-shi	Okayama-ken	Japan
23	Pfizer Investigational Site	Koshigaya	Saitama	Japan
24	Pfizer Investigational Site	Aoba-ku	Sendai-city	Japan
25	Pfizer Investigational Site	Meguro-ku	Tokyo	Japan
26	Pfizer Investigational Site	Minato-ku	Tokyo	Japan
27	Pfizer Investigational Site	Naka-ku	Yokohama-city Kanagawa	Japan
28	Pfizer Investigational Site	Fukushima		Japan
29	Pfizer Investigational Site	Kagoshima		Japan
30	Pfizer Investigational Site	Nagano		Japan
31	Pfizer Investigational Site	Okayama-city		Japan

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: NCT00871494
• Other Study ID Numbers: A0661192
• First Posted: Mar 30, 2009
• Last Update Posted: Nov 3, 2011
• Last Verified: Sep 1, 2011

• Additional relevant MeSH terms: Pelvic Inflammatory Disease; Pelvic Infection; Azithromycin

Study Results

Participant Flow

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Period Title: Overall Study
STARTED	76
COMPLETED	62
NOT COMPLETED	14

Baseline Characteristics

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Overall Participants	76
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32.2 (10.7)
Sex: Female, Male (Count of Participants)
Female	76 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	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)
Description	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.
Time Frame	End of Treatment, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Measure Participants	51
End of Treatment (n=51)	94.1 123.8%
Day 15 (n=51)	94.1 123.8%
Day 29 (n=46)	93.5 123%

2. Secondary Outcome

Title	Response Rate (Clinical Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Description	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.
Time Frame	End of Treatment, Day 15 and Day 29

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Measure Participants	51
End of Treatment (n=51)	92.2 121.3%
Day 15 (n=48)	100 131.6%
Day 29 (n=46)	100 131.6%

3. Secondary Outcome

Title	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)
Description	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.
Time Frame	End of treatment, Day 15, Day 29

Outcome Measure Data

Analysis Population Description

Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n" in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Measure Participants	36
End of treatment (n=31)	77.4 101.8%
Day 15 (n=34)	85.3 112.2%
Day 29 (n=31)	83.9 110.4%

4. Secondary Outcome

Title	Eradication Rate (Bacteriological Response, Investigator Assessment) in Participants Who Enrolled After Protocol Amendment (the Inclusion Criterion Regarding Fever of 37℃ or Higher Was Option)
Description	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.
Time Frame	End of treatment, Day 15, Day 29

Outcome Measure Data

Analysis Population Description

Bacteriologic per protocol set consisted of all participants in the clinical per protocol set in whom bacterial pathogens were identified at baseline. No imputation was used for missing data. "n" in the Measure Categories was the total participants EXCLUDING ones assessed as indeterminate.

Arm/Group Title	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
Measure Participants	36
End of treatment (n=14)	85.7 112.8%
Day 15 (n=11)	85.7 112.8%
Day 29 (n=19)	89.5 117.8%

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. 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	Azithromycin
Arm/Group Description	Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
All Cause Mortality
	Azithromycin
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Azithromycin
	Affected / at Risk (%)	# Events
Total	3/76 (3.9%)
Blood and lymphatic system disorders
Lymphadenitis	1/76 (1.3%)
Gastrointestinal disorders
Ileus	1/76 (1.3%)
Reproductive system and breast disorders
Ovarian haemorrhage	1/76 (1.3%)
Other (Not Including Serious) Adverse Events
	Azithromycin
	Affected / at Risk (%)	# Events
Total	35/76 (46.1%)
Gastrointestinal disorders
Abdominal pain upper	2/76 (2.6%)
Abdominal tenderness	3/76 (3.9%)
Constipation	3/76 (3.9%)
Diarrhoea	10/76 (13.2%)
Gastritis	2/76 (2.6%)
Nausea	4/76 (5.3%)
General disorders
Injection site pain	5/76 (6.6%)
Infections and infestations
Nasopharyngitis	4/76 (5.3%)
Vaginitis bacterial	2/76 (2.6%)
Vulvovaginal candidiasis	2/76 (2.6%)
Musculoskeletal and connective tissue disorders
Back pain	2/76 (2.6%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian neoplasm	2/76 (2.6%)
Nervous system disorders
Headache	3/76 (3.9%)
Pregnancy, puerperium and perinatal conditions
Ovulation pain	2/76 (2.6%)
Psychiatric disorders
Insomnia	2/76 (2.6%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain	2/76 (2.6%)
Skin and subcutaneous tissue disorders
Eczema	2/76 (2.6%)
Rash	2/76 (2.6%)
Urticaria	2/76 (2.6%)

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.