Pelvic Inflammatory DiseasePhase 4CTONCT01241110
To Compare Ofloxacin With Azitromycin for Pelvic Inflammatory Disease (PID) Treatment
A Phase 4 study testing Ofloxacin group A, Azitromycin group B and azitromycin in people with Pelvic Inflammatory Disease, run by Guilan University of Medical Sciences at 1 site in Iran.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Pelvic Inflammatory Disease
- What is being tested?
- Ofloxacin group A, Azitromycin group B and azitromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Sep 2010
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
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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.
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Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 4 Study of Azitromicin in the Treatment of PID
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
Read the detailed description
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
- Conditions
- Pelvic Inflammatory Disease
- Being tested
- Ofloxacin group A, Azitromycin group B, azitromycin
- Keywords
- PID, Ofloxacin, Azitromicine, Metronidazole
- 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.
Ofloxacin group A, Azitromycin group BDrug
Also called azitromicin, ofluxacin
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.
azitromycinDrug
Also called azitromicin, ofluxacin
azitromicin vs ofluxacin
| Study group | Role | What they receive |
|---|---|---|
| azitromicin,PID treatment,ofluxacin | Active comparator | Not described Receives: Drug: Ofloxacin group A, Azitromycin group B; Drug: azitromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
to compare two oral antibiotic protocols in terms of side effects and efficacy.
side effects- and efficacy
Measured: Jan 2010- Aug 2010
Secondary outcomes (1)
single oral dose of Azitromicine could be the drug of choice in the outpatient treatment of Pelvic Inflammatory Disease
compliance and cost
Measured: Jan 2010- Aug 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic Inflammatory DiseaseStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guilan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- Fariba Mirblook, MD, Principal investigator, Guilan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241110
- Sponsor's protocol ID
- ClinicalTrials.gov
- Other IDs
- R01DA013131
- Acronym
- CTO
- Status last verified
- Oct 2010
- First submitted
- 15 Nov 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of Azitromicin in the Treatment of PID
- ClinicalTrials.gov ID
- NCT01241110
- Acronym / sponsor ID
- CTO / ClinicalTrials.gov
- Conditions
- Pelvic Inflammatory Disease
- Keywords
- PID, Ofloxacin, Azitromicine, Metronidazole
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Guilan University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| azitromicin,PID treatment,ofluxacin | Active comparator | Drug: Ofloxacin group A, Azitromycin group B, Drug: azitromycin |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Ofloxacin group A, Azitromycin group BAlso: azitromicin, ofluxacinGroup 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. | Drug | azitromicin,PID treatment,ofluxacin |
| azitromycinAlso: azitromicin, ofluxacinazitromicin vs ofluxacin | Drug | azitromicin,PID treatment,ofluxacin |
Primary outcome
to compare two oral antibiotic protocols in terms of side effects and efficacy.
Time frame: Jan 2010- Aug 2010
side effects- and efficacy
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
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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.
Fariba Mirblook, MD principal investigator
Guilan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ofloxacin group A, Azitromycin group B and azitromycin in people with Pelvic Inflammatory Disease, run by Guilan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
to compare two oral antibiotic protocols in terms of side effects and efficacy. (time frame: Jan 2010- Aug 2010). 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 16 Nov 2010.