Chlamydia InfectionNCT00578188
Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract
An observational study of Chlamydia Infection, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to determine if Chlamydial infections persist in the rectum of females who have had a sexually transmitted infection of Chlamydia. Read more about this study
- Who is it for?
- Ages 11 to 19 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chlamydia Infection
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to Jan 2008
- Phase
- Observational
- 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 11 to 19 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: 11-19 year old females from the Arkansas Children's Hospital Adolescent Center
Who may be able to join
- 11-19 years old
- Female
- Diagnosis of Chlamydia on enrollment visit
- Invitation to participate control group
Who cannot join
- Age out of range
- Negative Chlamydia screen (unless qualifies for control group)
- Unable to provide needed samples
Trial locations and contacts
1 site in 1 country.
United States1 site
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
The purpose of this study is to determine if Chlamydial infections persist in the rectum of females who have had a sexually transmitted infection of Chlamydia.
- Conditions
- Chlamydia Infection
- Keywords
- Adolescent Health, Sexually transmitted infection, Women's Health
- Medical subject headings
- Chlamydia Infections, Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RP100-400 | Subjects with Chlamydia. The control group will also be identified with these numbers. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startFeb 2006
- Primary completionJan 2008 (estimated)
- Study completionJan 2008 (estimated)
Why it stopped: Study redesigned and re-submitted to UAMS IRB under different study title and IRB number.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chlamydia InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Investigators
- Amy M Scurlock, MD, Principal investigator, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578188
- Sponsor's protocol ID
- IRB # 43921
- Other IDs
- ACH GL #039005
- Status last verified
- Apr 2016
- First submitted
- 19 Dec 2007
- Last updated
- 13 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Centers for Disease Control and Prevention (CDC). Chlamydia trachomatis genital infections--United States, 1995. MMWR Morb Mortal Wkly Rep. 1997 Mar 7;46(9):193-8.
PubMed 9072679Dean D, Suchland RJ, Stamm WE. Evidence for long-term cervical persistence of Chlamydia trachomatis by omp1 genotyping. J Infect Dis. 2000 Sep;182(3):909-16. doi: 10.1086/315778. Epub 2000 Aug 17.
PubMed 10950788Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS, Terho P, Lapworth MA. Chlamydia trachomatis in the pharynx and rectum of heterosexual patients at risk for genital infection. Ann Intern Med. 1985 Jun;102(6):757-62. doi: 10.7326/0003-4819-102-6-757.
PubMed 3888022Cotter TW, Ramsey KH, Miranpuri GS, Poulsen CE, Byrne GI. Dissemination of Chlamydia trachomatis chronic genital tract infection in gamma interferon gene knockout mice. Infect Immun. 1997 Jun;65(6):2145-52. doi: 10.1128/iai.65.6.2145-2152.1997.
PubMed 9169744Igietseme JU, Portis JL, Perry LL. Inflammation and clearance of Chlamydia trachomatis in enteric and nonenteric mucosae. Infect Immun. 2001 Mar;69(3):1832-40. doi: 10.1128/IAI.69.3.1832-1840.2001.
PubMed 11179361
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chlamydia Trachomatis Persistence in the Female Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00578188
- Acronym / sponsor ID
- IRB # 43921
- Conditions
- Chlamydia Infection
- Keywords
- Adolescent Health, Sexually transmitted infection, Women's Health
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study redesigned and re-submitted to UAMS IRB under different study title and IRB number.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Jan 2008 (estimated)
- Study completion
- Jan 2008 (estimated)
- First posted
- 21 Dec 2007 (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.
The purpose of this study is to determine if Chlamydial infections persist in the rectum of females who have had a sexually transmitted infection of Chlamydia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RP100-400 | – | –Subjects with Chlamydia. The control group will also be identified with these numbers. |
Who may qualify
- Ages
- 11 to 19 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 11-19 year old females from the Arkansas Children's Hospital Adolescent Center
Key inclusion criteria (4 listed)
- 11-19 years old
- Female
- Diagnosis of Chlamydia on enrollment visit
- Invitation to participate control group
Key exclusion criteria (3 listed)
- Age out of range
- Negative Chlamydia screen (unless qualifies for control group)
- Unable to provide needed samples
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2016.
- Background: PubMed 9072679Centers for Disease Control and Prevention (CDC). Chlamydia trachomatis genital infections--United States, 1995. MMWR Morb Mortal Wkly Rep. 1997 Mar 7;46(9):193-8.
- Background: PubMed 10950788Dean D, Suchland RJ, Stamm WE. Evidence for long-term cervical persistence of Chlamydia trachomatis by omp1 genotyping. J Infect Dis. 2000 Sep;182(3):909-16. doi: 10.1086/315778. Epub 2000 Aug 17.
- Background: PubMed 3888022Jones RB, Rabinovitch RA, Katz BP, Batteiger BE, Quinn TS, Terho P, Lapworth MA. Chlamydia trachomatis in the pharynx and rectum of heterosexual patients at risk for genital infection. Ann Intern Med. 1985 Jun;102(6):757-62. doi: 10.7326/0003-4819-102-6-757.
- Background: PubMed 9169744Cotter TW, Ramsey KH, Miranpuri GS, Poulsen CE, Byrne GI. Dissemination of Chlamydia trachomatis chronic genital tract infection in gamma interferon gene knockout mice. Infect Immun. 1997 Jun;65(6):2145-52. doi: 10.1128/iai.65.6.2145-2152.1997.
- Background: PubMed 11179361Igietseme JU, Portis JL, Perry LL. Inflammation and clearance of Chlamydia trachomatis in enteric and nonenteric mucosae. Infect Immun. 2001 Mar;69(3):1832-40. doi: 10.1128/IAI.69.3.1832-1840.2001.
- Arkansas Children's Hospital Main PageLink provided by the sponsor.
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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.
Amy M Scurlock, MD principal investigator
Arkansas Children's Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chlamydia Infection, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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 4 inclusion and 3 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: withdrawn, as of the sponsor's last update on 13 Apr 2016. 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 United States. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00578188, which also lists 5 linked publications.
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 13 Apr 2016.