Lymphogranuloma VenereumPhase 2SHORT-LGVNCT07767422
Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum.
A Phase 2 study testing Doxycline in people with Lymphogranuloma Venereum and no Anorectal Symptoms, run by University Hospital, Bordeaux at 14 sites in France.
Trial summary
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. However, recent European studies reported that about 25% of the anal LGV infections are asymptomatic. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Lymphogranuloma Venereum, no Anorectal Symptoms, Doxycycline
- What is being tested?
- Doxycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 14 sitesFrance
- Study dates
- Sep 2026to Nov 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Male sex at birth
- LGV-positive result on anal specimen using Nucleic Acid Amplification Test at screening
- Having taken at least doxycycline for two days (i.e 400 mg of doxycycline)
- Not having taken more than 7 days of doxycycline 200 mg per day
- No more than 12 days between the date of sampling and date of inclusion
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- No anorectal symptoms
- Individual available for participation and follow-up during the four weeks required for the study
- Affiliate or beneficiary of a social security scheme
- Free written informed consent signed by the participant or by a legal representative (in the event of the participant's inability to consent) and the investigator (no later than the day of inclusion and before any examination required by the research).
Who cannot join
- Individual with anorectal symptoms
- Antibiotic treatment with antichlamydial activity (fluoroquinolones, macrolides-lincosamides-streptogramins, tetracyclines and rifampicin) within 28 days before the screening visit
- Use of doxycycline post-exposure prophylaxis (Doxy-PEP)
- Participation in another study
- Individual under a measure of legal protection measure (safeguard of justice, guardianship or curatorship) or unable to consent
- Refusal to participate in the study
Show all 13Show fewer
- Mental state rendering the person giving consent incapable of understanding the entirety of the trial
- Participant detained by judicial or administrative decision.
- Individual receiving an anticoagulant therapy
- Individual with a history of known hypersensitivity to doxycycline or any other antibiotic of the tetracycline family or allergy to any of the excipients (Hydrogenated castor oil, povidone, anhydrous colloidal silica, magnesium stearate, microcrystalline cellulose, sodium carboxymethyl starch (type A)).
- Individual treated with retinoids by general route.
- Individual receiving 10,000 IU of vitamin A per day or more
- Individual being a relative of the investigator or a relative of someone from the team directly involved in the trial, including assistant doctors, pharmacists, nurses, and trial coordinators
Trial locations and contacts
14 sites in 1 country. Contact the study team or a site near you to ask about taking part.
14 sites in 1 country
France14 sites
University Hospital, Bordeaux, Department of Infectious Diseases
Bordeaux, 33000
Charles CAZANAVE, Pr, 05 56 79 55 36 ext. +33, charles.cazanave@chu-bordeaux.fr
Olivia PEUCHANT, PharmD, 05 57 62 34 70 ext. +33, olivia.peuchant@u-bordeaux.fr
Hopital François Mitterrand, Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Dijon, 21079
NATHALIE NOELLAT, MD, 09 80 28 14 63 ext. +33, nathalie.noellat@chu-dijon.fr
NATHALIE NOELLAT, MD
Hospices Civils de Lyon, Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Lyon, 69004
MAXIME BONJOUR, MD, 04 26 37 24 58 ext. +33, maxime.bonjour@chu-lyon.fr
MAXIME BONJOUR, MD
Service de Prevention Aupres Des Jeunes, Ceggid
Marseille, 13331
PERVENCHE MARTINET, MD, 04 13 31 29 72 ext. +33, pervenche.martinet@departement13.fr
Hopital Intercommunal Andre Gregoire - Ght , Centres Gratuits D'Information, de Depistage Et de Diagnostic (Ceggid)
Montreuil, 93100
Chu de Nantes, Maladies Infectieuses (Cpmit)
Nantes, 44093
ESTELLE PASQUIER, MD, 02 40 73 07 36 ext. +33, estelle.pasquier@chu-nantes.fr
ESTELLE PASQUIER, MD
Hotel-Dieu, Service Des Maladies Infectieuses Et Tropicales
Paris, 75004
LAURENCE SLAMA, MD, 01 42 34 79 58 ext. +33, laurence.slama@aphp.fr
Laurence SLAMA, MD
Hopital La Pite Salpetriere, Service Des Maladies Infectieuses Et Tropicales
Paris, 75013
GENTIANE MONSEL, MD, 01 84 82 73 71 ext. +33, gentiane.monsel@aphp.fr
GENTIANE MONSEL, MD
Hopital Bichat - Claude Bernard, Ceggid
Paris, 75018
JADE GHOSN, MD, 01 40 25 78 03 ext. +33, jade.ghosn@aphp.fr
JADE GHOSN, MD
Hopital Bichat - Claude Bernard, Service Des Maladies Infectieuses Et Tropicales
Paris, 75018
JADE GHOSN, MD, 01 40 25 78 03 ext. +33, jade.ghosn@aphp.fr
JADE GHOSN, MD
Hopital Saint-Louis, Service Des Maladies Infectieuses Et Tropicales
Paris
CLAIRE PINTADO, MD, 01 42 49 49 73 ext. +33, claire.pintado@aphp.fr
CLAIRE PINTADO, MD
Chu Toulouse Purpan, Service Des Maladies Infectieuses Et Tropicales
Toulouse, 31059
GUILLAUME MARTIN-BLONDEL, MD, 05 61 77 96 99 ext. +33, martin-blondel.g@chu-toulouse.fr
Centre Hospitalier de Tourcoing, Ceggid
Tourcoing, 59208
Centre Hospitalier de Tourcoing, Service Des Maladies Infectieuses Et Tropicales
Tourcoing, 59208
OLIVIER ROBINEAU, MD, 03 20 69 46 13 ext. +33, orobineau@ch-tourcoing.fr
Olivier ROBINEAU, MD
About this study
Official title: Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. However, recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. LGV testing is recommended on all C. trachomatis-positive anorectal specimens because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). The objective of this study is to evaluate the efficacy (microbiological cure rate) of a 7-day course of doxycycline 200 mg daily orally for the treatment of asymptomatic anal LGV infection, four weeks after treatment initiation.
Read the detailed description
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. LGV have reemerged in Europe, primarily in men who have sex with men (MSM). The number of LGV cases reported has risen year on year, from 739 in 2011 to 3124 in 2019 in European countries. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. Recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. Guidelines on the management of LGV recommended that all MSM with anorectal C. trachomatis-positive specimens should be tested for LGV irrespective of symptoms. However, access to routine LGV testing is inconsistent in France and other European countries, and specimens need to be referred to expert laboratories with substantial additional cost and significant delay to receiving results. LGV testing is recommended because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). These results suggest that a shorter course of doxycycline could be sufficient for treating asymptomatic anal LGV. In this study, subjects without anorectal symptoms and with anal specimens positive for LGV will be treated by a 7-day course of doxycycline 200 mg daily orally. The microbiological cure will be estimated four weeks after treatment initiation, with a self-collected anal specimen for the detection of LGV
- Conditions
- Lymphogranuloma Venereum, no Anorectal Symptoms, Doxycycline
- Being tested
- Doxycline
- Keywords
- Lymphogranuloma venereum, Chlamydia trachomatis, asymptomatic, doxycycline
- Medical subject headings
- Lymphogranuloma Venereum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DoxyclineDrug
Doxycycline 200 mg daily orally for seven days
| Study group | Role | What they receive |
|---|---|---|
| Doxycycline | Experimental | Not described Receives: Drug: Doxycline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiological cure rate of a 7-day course of doxycycline for asymptomatic anal LGV
The microbiological cure is defined as a LGV-negative NAAT (Nucleic Acid Amplification Test) result in anal specimens four weeks after treatment initiation, among participants with a LGV-positive NAAT result at baseline.
Measured: 4 weeks after treatment initiation
Secondary outcomes (5)
Differentiation of reinfection from treatment failure at Week 4
Genotyping (ompA gene) of C. trachomatis-positive specimens obtained at week 4 to differentiate reinfection (different ompA-genotype, or unprotected anal intercourse with an untreated/new partner) from treatment failure (identical ompA-genotype, or no anal intercourse/consistent condom use since inclusion).
Measured: 4 weeks after treatment initiation
Chlamydia trachomatis bacterial load in anal specimens
- trachomatis load will be measured at baseline and four weeks after treatment initiation using quantitative real-time PCR, reported as the number of DNA copies per microliter.
Measured: Baseline and 4 weeks after treatment initiation
Molecular mechanisms of doxycycline resistance
Identification of molecular mechanisms for doxycycline resistance by amplification and sequencing of target genes (including 16S rRNA gene) in all LGV-positive specimens collected at baseline and four weeks after treatment initiation.
Measured: Baseline and 4 weeks after treatment initiation
Adherence to doxycycline treatment
Adherence to the 7-day doxycycline regimen will be evaluated using a patient self-completed daily diary, along with pill count and return of treatment packaging at the inclusion and follow-up visits.
Measured: From treatment initiation to 4 weeks after treatment initiation
Incidence of adverse events and serious adverse events
Number and percentage of participants experiencing adverse events (AEs) and serious adverse events (SAEs) related or unrelated to doxycycline, recorded in the e-CRF
Measured: up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2026
- Study startSep 2026 (estimated)
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphogranuloma VenereumStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07767422
- Sponsor's protocol ID
- CHUBX 2025/069
- Acronym
- SHORT-LGV
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Study Evaluating the Efficacy of a 7-day Course of Doxycycline for the Treatment of Asymptomatic Anal Lymphogranuloma Venereum
- ClinicalTrials.gov ID
- NCT07767422
- Acronym / sponsor ID
- SHORT-LGV / CHUBX 2025/069
- Conditions
- Lymphogranuloma Venereum, no Anorectal Symptoms, Doxycycline
- Keywords
- Lymphogranuloma venereum, Chlamydia trachomatis, asymptomatic, doxycycline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- 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.
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. However, recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. LGV testing is recommended on all C. trachomatis-positive anorectal specimens because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). The objective of this study is to evaluate the efficacy (microbiological cure rate) of a 7-day course of doxycycline 200 mg daily orally for the treatment of asymptomatic anal LGV infection, four weeks after treatment initiation.
Detailed description
Lymphogranuloma venereum (LGV) is a sexually transmitted infection (STI) caused by the L genotypes of C. trachomatis. LGV have reemerged in Europe, primarily in men who have sex with men (MSM). The number of LGV cases reported has risen year on year, from 739 in 2011 to 3124 in 2019 in European countries. Proctitis is the main clinical manifestation of infection in the current LGV epidemic. Recent European studies reported that about 25% of the anal LGV infections are asymptomatic. In France, asymptomatic anal LGV increased from 36.1% (44/124) in 2020 to 52.4% (66/126) in 2022. Guidelines on the management of LGV recommended that all MSM with anorectal C. trachomatis-positive specimens should be tested for LGV irrespective of symptoms. However, access to routine LGV testing is inconsistent in France and other European countries, and specimens need to be referred to expert laboratories with substantial additional cost and significant delay to receiving results. LGV testing is recommended because therapy of extended duration is required. Patients with anal C. trachomatis infection should be treated initially with 7-day course of doxycycline (200 mg per day orally) while awaiting the results of LGV testing. Treatment should be extended to 21 days in cases of LGV according to current European and USA guidelines for LGV treatment. This regimen is indicated for symptomatic and asymptomatic anorectal LGV, with a 98.5% treatment efficacy. However, there is no obvious biological basis for prolonged treatment of asymptomatic LGV. Three recent retrospective studies showed that a 7-day course of doxycycline was effective for the treatment of asymptomatic LGV, with microbial cure ranging from 97% (38/39) to 100% (54/54). These results suggest that a shorter course of doxycycline could be sufficient for treating asymptomatic anal LGV. In this study, subjects without anorectal symptoms and with anal specimens positive for LGV will be treated by a 7-day course of doxycycline 200 mg daily orally. The microbiological cure will be estimated four weeks after treatment initiation, with a self-collected anal specimen for the detection of LGV
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Doxycycline | Experimental | Drug: Doxycline |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Male sex at birth
- LGV-positive result on anal specimen using Nucleic Acid Amplification Test at screening
- Having taken at least doxycycline for two days (i.e 400 mg of doxycycline)
- Not having taken more than 7 days of doxycycline 200 mg per day
Key exclusion criteria (13 listed)
- Individual with anorectal symptoms
- Antibiotic treatment with antichlamydial activity (fluoroquinolones, macrolides-lincosamides-streptogramins, tetracyclines and rifampicin) within 28 days before the screening visit
- Use of doxycycline post-exposure prophylaxis (Doxy-PEP)
- Participation in another study
- Individual under a measure of legal protection measure (safeguard of justice, guardianship or curatorship) or unable to consent
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 |
|---|---|---|
| DoxyclineDoxycycline 200 mg daily orally for seven days | Drug | Doxycycline |
Primary outcome
Microbiological cure rate of a 7-day course of doxycycline for asymptomatic anal LGV
Time frame: 4 weeks after treatment initiation
The microbiological cure is defined as a LGV-negative NAAT (Nucleic Acid Amplification Test) result in anal specimens four weeks after treatment initiation, among participants with a LGV-positive NAAT result at baseline.
5 secondary outcomes
Differentiation of reinfection from treatment failure at Week 4
Time frame: 4 weeks after treatment initiation
Chlamydia trachomatis bacterial load in anal specimens
Time frame: Baseline and 4 weeks after treatment initiation
Molecular mechanisms of doxycycline resistance
Time frame: Baseline and 4 weeks after treatment initiation
Adherence to doxycycline treatment
Time frame: From treatment initiation to 4 weeks after treatment initiation
Incidence of adverse events and serious adverse events
Time frame: up to 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Doxycline in people with Lymphogranuloma Venereum and no Anorectal Symptoms, run by University Hospital, Bordeaux at 14 sites in France.
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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Charles CAZANAVE, Pr (05 56 79 55 36 ext. +33, charles.cazanave@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiological cure rate of a 7-day course of doxycycline for asymptomatic anal LGV (time frame: 4 weeks after treatment initiation). 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 17 Aug 2026.