To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment (CTO)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01241110 |
Recruitment Status
:
Completed
First Posted
: November 16, 2010
Last Update Posted
: November 16, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Objective: To compare two oral treatments: Ofloxacin + Metronidazole, and Azitromycin +Metronidazole in outpatients with Pelvic Inflammatory Disease.
Materials and Methods: Two hundred patients divided to two groups( A , B). Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pelvic Inflammatory Disease | Drug: Ofloxacin group A, Azitromycin group B Drug: azitromycin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase 4 Study of Azitromicin in the Treatment of PID |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | August 2010 |
Actual Study Completion Date : | September 2010 |

Arm | Intervention/treatment |
---|---|
Active Comparator: azitromicin,PID treatment,ofluxacin |
Drug: Ofloxacin group A, Azitromycin group B
Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy.
Other Name: azitromicin, ofluxacin
Drug: azitromycin
azitromicin vs ofluxacin
Other Names:
|
- to compare two oral antibiotic protocols in terms of side effects and efficacy. [ Time Frame: Jan 2010- Aug 2010 ]side effects- and efficacy
- single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease [ Time Frame: Jan 2010- Aug 2010 ]compliance and cost

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:Eligibility criteria were having three out of five following symptoms: a-lower abdominal pain, b-vaginal discharges, c- adnexal tenderness, d-cervical motion tenderness (CMT), e-cervisitis.
Exclusion Criteria:Excluding criteria were as follows: a-unmarried women, b-pregnant women, c-women with infection during menstruation, d- history of abortion or miscarriage during the last month, e-underlying diseases such as diabetes, f-used antibiotics in the last month, or allergy to the antibiotics used in the study, g-history of Pelvic Inflammatory Disease within the last year, and h- suspicion of being multi partner.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01241110
Iran, Islamic Republic of | |
Alzahra Maternity Hospital | |
Rasht, Guilan, Iran, Islamic Republic of, 16746 |
Principal Investigator: | Fariba Mirblook, MD | Guilan University of Medical Sciences |
Responsible Party: | fariba mirblook, GUMS |
ClinicalTrials.gov Identifier: | NCT01241110 History of Changes |
Other Study ID Numbers: |
ClinicalTrials.gov R01DA013131 ( U.S. NIH Grant/Contract ) |
First Posted: | November 16, 2010 Key Record Dates |
Last Update Posted: | November 16, 2010 |
Last Verified: | October 2010 |
Keywords provided by Guilan University of Medical Sciences:
PID, Ofloxacin, Azitromicine, Metronidazole |
Additional relevant MeSH terms:
Pelvic Inflammatory Disease Pelvic Infection Adnexal Diseases Genital Diseases, Female Infection Metronidazole Ofloxacin Levofloxacin Anti-Infective Agents Antiprotozoal Agents Antiparasitic Agents |
Anti-Infective Agents, Urinary Renal Agents Anti-Bacterial Agents Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Cytochrome P-450 CYP1A2 Inhibitors Cytochrome P-450 Enzyme Inhibitors |