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    Summary
    EudraCT Number:2019-002829-29
    Sponsor's Protocol Code Number:ANRS174
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-10-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedFrance - ANSM
    A.2EudraCT number2019-002829-29
    A.3Full title of the trial
    Combined Prevention of Sexually Transmitted Infections (STIs) in Men Who Have Sex with Men using oral TDF/FTC for HIV Pre-Exposure Prophylaxis (PrEP)
    Prévention combinée des infections sexuellement transmissibles (IST) chez les hommes ayant des rapports sexuels avec des hommes utilisant le TDF/FTC par voie orale pour la prophylaxie préexposition au VIH (PrEP)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of preventive treatements against bacterial STIs in PrEP users
    Comparaison de traitements préventifs des IST bactériennes chez les PrEPeurs
    A.3.2Name or abbreviated title of the trial where available
    Doxyvac
    A.4.1Sponsor's protocol code numberANRS174
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorINSERM ANRS
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportANRS
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSERM ANRS
    B.5.2Functional name of contact pointDelphine LEBRASSEUR-LONGUET
    B.5.3 Address:
    B.5.3.1Street Address101 rue de Tolbiac
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75013
    B.5.3.4CountryFrance
    B.5.4Telephone number+33153946036
    B.5.5Fax number+33153946003
    B.5.6E-maildelphine.lebrasseur@anrs.fr
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Bexsero
    D.2.1.1.2Name of the Marketing Authorisation holderGSK Vaccines S.r.l.
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Suspension for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    MSM with at least 6-month experience with PrEP (Pre-Exposure Prophylaxis)
    HSH prenant la PrEP (Prophylaxie Pré-Exposition) depuis au moins 6 mois
    E.1.1.1Medical condition in easily understood language
    MSM with at least 6-month experience with PrEP (Pre-Exposure Prophylaxis)
    HSH prenant la PrEP (Prophylaxie Pré-Exposition) depuis au moins 6 mois
    E.1.1.2Therapeutic area Diseases [C] - Bacterial Infections and Mycoses [C01]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    - To demonstrate that post-exposure prophylaxis (PEP) with doxycycline reduces the occurrence of a first episode of syphilis or Chlamydia trachomatis
    - To demonstrate that the meningococcal B vaccine (Bexsero®) reduces the occurrence of first episode of Neisseria Gonorrheae
    - Démontrer que la prophylaxie post-exposition (PEP) avec la doxycycline réduit la survenue d’un premier épisode de syphilis ou d’infection par Chlamydia trachomatis
    - Démontrer que la vaccination contre le méningocoque B réduit la survenue d’un premier épisode d’infection par Neisseria gonorrhoeae
    E.2.2Secondary objectives of the trial
    - PEP-doxy : reduction in the occurrence of a 1st episode ofsyphilis (TP), chlamydia (CT, gonorrhea (NG) and Mycoplasma genitalium (MG), all cumulative episodes of TP, CT, NG and MG, a new episode of anal or urinary NG, a 1st episode of symptomatic anal and urinary NG or CT; impact on human microbiota; tolerance and compliance; antibiotic suceptibility; comparison of resistome and clonality of NG strains and negativity rate of STI diagnostic tests
    - Bexsero: reduction in the occurrence of cumulative episodes of NG, 1st episode of anal and urinary NG, 1st episode of symptomatic anal and urinary NG; serum bactericidal activity against meningococcus B and gonococci; tolerance
    - Prevalence and incidence of meningococcal carrying at the pharyngeal, anal and urinary levels and the impact of prophylaxis on it
    - Impact of each prophylaxis strategy on sexual behaviour and HIV incidence
    - PEP-doxy : réduction de la survenue d’un 1er épisode de syphilis (TP), chlamydia (CT), gonorrhée (NG) et Mycoplasma genitalium (MG), tous les épisodes cumulés de TP, CT, NG et MG, d’un nouvel épisode de NG anale ou urinaire, d’un 1er épisode symptomatique de NG ou CT anale et urinaire ; impact sur le microbiome humain ; tolérance et observance ; résistance aux antibiotiques ; comparaison du résistome et de la clonalité des souches de NG et du taux de négativité des tests diagnostiques des IST
    - Bexsero : réduction de la survenue d’épisodes cumulés de NG, d’un 1er épisode de NG anale et urinaire, d’un 1er épisode de NG symptomatique anale et urinaire ; activité bactéricide du serum contre le méningocoque B et les gonocoques ; tolérance
    - Prévalence et incidence du portage du méningocoque au niveau pharyngé, anal et urinaire et impact de la prophylaxie sur celui-ci
    - Impact de chaque stratégie de prophylaxie sur le comportement sexuel et sur l'incidence du VIH
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    "Intestinal Microbiota" substudy : Impact of doxycycline PEP on the human microbiome
    Detection from throat swab of carriage of Methicillin-Resistant Staphylococcus Aureus (MRSA) and doxycycline resistant staphylococci and from fecal carriage of Extended Spectrum Beta-Lactamase (ESBL)-producing Enterobacteriaceae)
    2019-09-20 version
    Etude ancillaire "Microbiote intestinal" : évaluation de l'impact de la doxycycline administrée en PEP sur le microbiome humain
    Détection à partir du prélèvement de gorge de Staphylococcus aureus résistant à la méthicilline (SARM) et/ou de Staphylococcus aureus résistants à la doxycycline et à partir du portage fécal d'entérobactéries productrices de bêta-lactamase à spectre étendu (BLSE)
    Version du 20-09-2019
    E.3Principal inclusion criteria
    • MSM enrolled in the ANRS PREVENIR study
    • At least 6-month experience with PrEP (within the ANRS PREVENIR study or before starting the ANRS PREVENIR study)
    • No clinical manifestation of primary HIV infection and no symptom of bacterial STI (chlamydia, gonorrhea, M. genitalium or syphilis)
    • History of documented bacterial STI with at least one episode in the last 12 months
    • Participants who agree to sign the information and consent form specific to this study
    • Valid health insurance (“Aide Médicale d'Etat AME” is not health insurance)
    • HSH participant à l’étude ANRS PREVENIR
    • Prenant la PrEP depuis au moins 6 mois (dans l’étude ANRS PREVENIR ou avant de participer à l’étude ANRS PREVENIR)
    • Pas de signe clinique d’infection VIH et pas de symptôme d’infection par une IST bactérienne (chlamydia, gonorrhée, Mycoplasma genitalium or ou syphilis)
    • Antécédent documenté d’infection par une IST bactérienne dans les 12 derniers mois
    • Consentement libre, éclairé, écrit, signé par la personne et l'investigateur au plus tard le jour de l'inclusion et avant tout examen réalisé dans le cadre de l'étude (article L1122-1-1 du Code de la Santé Publique)
    • Personne affiliée ou bénéficiaire d'un régime de sécurité sociale (article L1121-11 du Code de la Santé Publique) (l'Aide Médicale d'Etat ou AME n'est pas un régime de sécurité sociale)
    E.4Principal exclusion criteria
    • Syphilis diagnosed prior to inclusion without serologic evidence of cure (cure is defined as decreased by at least 4-fold of the non-treponemal antibody titer [VDRL, RPR] relative to the titer at initiation of treatment of syphilis)
    • HIV infection.
    • Previous vaccination with Bexsero®
    • Systemic treatment with retinoids (Acnetrait®, Procuta®, Curacné®, Contracné®, ….).
    • Treatment with enzyme-inducing anticonvulsants (carbamazepine, phenobarbital, phenytoïne, ….)
    • Known or documented failure of the immune system, which would impair the immune response to the vaccine, such as subjects with inherited deficiency of complement, or immunosuppressive therapy
    • Known allergy to antibiotics of the tetracycline family
    • Known allergy to any component of the Bexsero® vaccine
    • Known allergy to any component of the doxycycline pill
    • Known allergy to latex (contained in the vaccine cap)
    • Thrombocytopenia or any other known coagulation disorder, which would be a contraindication to an intramuscular injection of Bexsero® vaccine
    • Documented esophageal lesion
    • Continuous treatment with doxycycline at D0DV/inclusion
    • Vitamin A treatment in case of intake of 10 000IU/d or more
    • Participation in another research including an exclusion period still in progress at the time of inclusion
    • Under guardianship or curatorship, or deprived of liberty by a judicial or administrative decision
    • Syphilis diagnostiquée avant l’inclusion sans preuve sérologique de guérison (la guérison étant définie comme une diminution d'au moins 4 fois du titre d'anticorps non-tréponémique [VDRL, RPR] par rapport au titre au début du traitement de la syphilis)
    • Infection par le VIH
    • Antécédent de vaccination par Bexsero®
    • Traitement systémique aux rétinoïdes (Acnetrait®, Procuta®, Curacné®, Contracné®, ....)
    • Traitement par anticonvulsivants inducteurs enzymatiques (carbamazépine, phénobarbital, phénytoïne, ...)
    • Défaut connu ou documenté du système immunitaire, qui empêcherait une réponse immunitaire au vaccin, tel que des sujets présentant des déficits héréditaires du complément, ou suivant un traitement immunosuppresseur
    • Allergie connue aux antibiotiques de la famille des tétracyclines
    • Allergie connue à l'un des composants du vaccin Bexsero®
    • Allergie connue à l'un des composants des comprimés de doxycycline
    • Allergie connue au latex (pour la vaccination, le capuchon de la seringue peut contenir des traces de latex)
    • Thrombopénie ou tout autre trouble de la coagulation connu, qui serait une contre-indication à une injection par voie intramusculaire du vaccin Bexsero®
    • Lésion œsophagienne documentée
    • Traitement continu avec la doxycycline au moment de l’inclusion
    • Traitement à avec la vitamine A en cas d'ingestion à une dose de 10 000 UI/j ou plus
    • Personne participant à une autre recherche comprenant une période d'exclusion toujours en cours à l'inclusion
    • Personne sous tutelle ou curatelle, ou privée de liberté par une décision judiciaire ou administrative
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for intervention 1 (with or without doxycycline PEP) is the first episode of chlamydia or syphilis after the enrolment visit (J0DV) (chlamydia and syphilis diagnosed at the enrolment visit will not be included in the primary endpoint).
    The primary endpoint for intervention 2 (with or without Bexsero® vaccine) is the first episode of gonorrhea reported one month after the second vaccine injection, so starting at the month 3 visit (gonorrhea episodes diagnosed at the enrolment visit and before the month 3 visit will not be included in the primary endpoint).
    In these analyses, subject follow-up will be right-censored at the time of the first STI.
    Le critère principal de jugement de l'intervention 1, doxycycline en PEP ou pas de PEP, est le premier épisode de syphilis ou de chlamydia déclaré après la visite d’inclusion J0DV (les infections par syphilis et chlamydia diagnostiquées à J0DV ne seront pas prises en compte pour le critère principal de jugement).
    Le critère principal de jugement de l'intervention 2, vaccin Bexsero® ou absence de vaccin, est le premier épisode de gonorrhée déclaré un mois après la deuxième injection, c’est-à-dire à partir de la visite M3DV (les infections à gonocoques diagnostiquées entre J0DV et la visite M3DV ne seront pas prises en compte pour le critère principal de jugement).
    Dans ces analyses, le suivi du sujet sera censuré au moment de la première IST.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Intervention 1 : the date of the first episode of syphilis or chlamydia after the enrolment visit (J0DV)
    Intervention 2 : the date of the first episode of gonorrhea reported one month after the second vaccine injection
    Intervention 1 : date du premier épisode de syphilis ou chlamydia après la visite d’inclusion (J0DV)
    Intervention 2 : date du premier épisode de gonorrhée reporté un mois après la seconde vaccination
    E.5.2Secondary end point(s)
    The following secondary criteria will be compared between the treatment arms:
    1- Occurrence of a first episode of each of the bacterial STIs as well as cumulative incidence of each bacterial STIs (syphilis, chlamydia; gonorrhoea and Mycoplasma genitalium) during the trial. In that case, the entire follow-up will be considered.
    2- Occurrence of a new episode of anal or urinary gonorrhoea.
    3- Occurrence of a first symptomatic episode of chlamydia infection or gonorrhea at urinary or anal sites.
    4- Impact of doxycycline PEP on the human microbiota: detection from throat swab of carriage of Methicillin-Resistant Staphylococcus aureus (MRSA) and/or doxycycline resistant Staphylococcus aureus, fecal carriage of Extended Spectrum Beta-Lactamase (ESBL)-producing Enterobacteriaceae, and composition of the intestinal microbiota).
    5- Safety and adherence to PEP.
    6- Antibiotic susceptibilities of all strains of NG, CT, MG to doxycycline, macrolides, fluoroquinolones and third generation cephalosporin for gonorrhea or TP PCR-positive samples with and without PEP.
    7- Rate of cured STIs after treatment with or without PEP.
    8- Composition of the resistome and clonality of Neisseria gonorrhoeae strains with or without doxycycline.
    9- Serum bactericidal activity against meningococcal and gonococcal antigens over time in participants of Bexsero®’s arm.
    10- Safety of Bexsero® vaccine.
    11- Prevalence and incidence of meningococcal carriage in pharyngeal, anal and urine swabs.
    12- Impact of PEP or Bexsero® vaccine on sexual behaviour (rates of condom use for receptive anal intercourse, number of sexual partners and number of sex acts over time).
    13- Incidence of HIV infection with both prophylaxis strategies.
    Les critères secondaires suivants seront comparés entre les bras de traitement :
    1- La survenue d'un premier épisode de chacune des IST bactériennes ainsi que l'incidence cumulée de chaque IST bactérienne (syphilis, chlamydia, gonorrhée et Mycoplasma genitalium) au cours de l'étude. Dans ce cas, la totalité du suivi sera prise en compte.
    2- La survenue d'un nouvel épisode de gonorrhée anale ou urinaire.
    3- La survenue d’un premier épisode symptomatique de gonorrhée ou d’infection à chlamydiae anale ou urinaire.
    4- L’évaluation de l'impact de la doxycycline administrée en PEP sur le microbiote humain : détection à partir du prélèvement de gorge de Staphylococcus aureus résistant à la méthicilline (SARM) et/ou de Staphylococcus aureus résistants à la doxycycline et sur le portage fécal d'entérobactéries productrices de bêta-lactamase à spectre étendu (BLSE) et l’étude de la composition du microbiote intestinal (étude ancillaire « microbiote intestinal » 30 participants dans le centre de l'Hôpital Saint-Louis).
    5- La tolérance et l’observance de la PEP avec doxycycline.
    6- La sensibilité aux antibiotiques de toutes les souches de Neisseria gonorrhoeae (NG), de Chlamydia trachomatis (CT), et l’absence ou la présence de mutations associées à la résistance à la doxycycline dans les échantillons Mycoplasma genitalium (MG) ou Treponema pallidum (TP)-PCR positifs avec ou sans doxycycline en PEP.
    7- Le taux d’IST guéries après traitement avec ou sans PEP.
    8- La composition du résistome et de la clonalité des souches de Neisseria gonorrhoeae avec ou sans doxycycline.
    9- L'activité bactéricide du sérum contre le méningocoque B et les gonocoques au cours du temps chez les participants vaccinés.
    10- La tolérance du vaccin Bexsero®.
    11- Prévalence et incidence du portage du méningocoque au niveau pharyngé, anal et urinaire.
    12- Le taux d'utilisation du préservatif pour les relations anales, le nombre de partenaires sexuels et le nombre d'actes sexuels au cours du temps.
    13- L'incidence de l'infection par le VIH.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1- 2- 3- M3DV, M6DV, M9DV, M12DV, M15DV, M18DV, M21DV and M24DV
    4- At M12DV
    5- At each visit : M3DV, M6DV, M9DV, M12DV, M15DV, M18DV, M21DV and M24DV
    6- M12DV
    7- 3 to 4 weeks after the completion of the specific treatment for STIs
    8- M12DV
    9- M2DV, M3DV and M12DV
    10- At each visit : M2DV, M3DV, M6DV, M9DV, M12DV, M15DV, M18DV, M21DV and M24DV
    11- At each visit : M3DV, M6DV, M9DV, M12DV, M15DV, M18DV, M21DV and M24DV
    12- At each visit : M3DV, M6DV, M9DV, M12DV, M15DV, M18DV, M21DV and M24DV
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    24 months after the first inclusion + 6 month for analysis and results
    24 mois après la première inclusion + 6 mois pour analyses et obtention des résultats
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 720
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state720
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Doxycycline is taken as a preventive treatment for STIs as part of research. It will not be possible to continue doxycycline treatment in PEP after the end of the research until final results have been obtained on the risk of selection of bacteria resistant to this antibiotic.
    La prise de doxycycline en traitement préventif des IST s’effectue dans le cadre de la recherche. Il ne sera pas possible de poursuivre le traitement par doxycycline en PEP après la fin de la recherche avant d’avoir obtenu les résultats définitifs sur le risque de sélection de bactéries résistantes à cet antibiotique.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-12-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-12
    P. End of Trial
    P.End of Trial StatusCompleted
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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