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COMPLETED Phase 2

Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women

NCT01631201 · View on ClinicalTrials.gov ↗

Study Summary

This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a single dose to women who have genital chlamydial infection.

Interventions

  • DRUG Rifalazil 25 milligram
  • DRUG Azithromycin 1 gram

Study Locations (5)

Alabama

  • Research Site — Birmingham

California

  • Research Site — San Diego

Indiana

  • Research Site — Indianapolis

Nevada

  • Research Site — Las Vegas

Virginia

  • Research Site — Virginia Beach

Trial Details

FieldValue
Enrollment Target 82 participants
Start Date 2012-07
Est. Completion 2013-04
Phase Phase 2

Sponsor

ActivBiotics Pharma

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01631201

The ClinicalTrials.gov registry entry for NCT01631201 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is ActivBiotics Pharma, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Chlamydia Trachomatis Infection appearing as the primary indexed condition, and to 2 interventions — of which Rifalazil 25 milligram is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01631201 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Alabama, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01631201 about?

NCT01631201 is a clinical study titled "Safety and Efficacy Study of Rifalazil for the Treatment of Chlamydia Trachomatis Infection in Women". This study will test the safety and effectiveness of an investigational antibiotic drug, rifalazil for the treatment of uncomplicated genital Chlamydia trachomatis infection. This study will examine the effects of 25 milligram of rifalazil compared with azithromycin 1 gram, which will be given as a ...

What is the current status of trial NCT01631201?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 82 participants. The study started on 2012-07. Estimated completion is 2013-04.

What conditions does trial NCT01631201 study?

This clinical trial studies the following conditions: Chlamydia Trachomatis Infection. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01631201?

The interventions under investigation include: Rifalazil 25 milligram (DRUG), Azithromycin 1 gram (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01631201?

This trial is sponsored by ActivBiotics Pharma, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01631201 being conducted?

This trial has 5 study locations across Alabama, California, Indiana, Nevada, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial