Doxycycline for Sexually Transmitted Infections
(DOT-Doxy-PEP Trial)
Recruiting in Palo Alto (17 mi)
Overseen byMatthew Spinelli, MD, MAS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase < 1
Recruiting
Sponsor: University of California, San Francisco
Must be taking: Gender affirming hormones
Must not be taking: Doxycycline
Disqualifiers: Pregnancy, Liver disease, Hypersensitivity, others
No Placebo Group
Approved in 5 Jurisdictions
Trial Summary
What is the purpose of this trial?Rates of bacterial sexually transmitted infections (STIs) are rising globally, demanding innovative interventions beyond the scope of current efforts to prevent STIs. The United States Doxycycline Post-exposure Prophylaxis (DoxyPEP) Study has demonstrated the efficacy of doxycycline post-exposure prophylaxis (PEP) among men who have sex with men and transgender women; but puzzlingly, doxycycline PEP was found ineffective in cisgender women in the Kenyan doxycycline Post-Exposure Prophylaxis (dPEP) study, with preliminary data suggesting the low medication adherence may explain the null result. By study end, the investigators will have developed adherence measurement methods for doxycycline in hair, blood, and urine, and will use these techniques to help interpret the Kenyan dPEP study, and to examine the relative performance of these methods within the United States DoxyPEP trial, establishing adherence metrics for current and future rollout studies of doxycycline post-exposure prophylaxis
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are a transgender participant, you must continue using your gender-affirming hormone therapy.
What data supports the effectiveness of the drug doxycycline for sexually transmitted infections?
Doxycycline has been shown to be effective in treating sexually transmitted infections like Chlamydia trachomatis and gonorrhea, with high cure rates reported in studies. It is well-tolerated, has good tissue penetration, and is effective against several bacterial infections, making it a strong option for managing STIs.
12345Is doxycycline generally safe for humans?
Doxycycline is generally well tolerated in humans, but it can cause stomach upset, nausea, and diarrhea. New formulations have been developed to reduce these side effects. It is not recommended for children, pregnant women after the second trimester, and breastfeeding mothers due to potential risks.
678910How does the drug doxycycline differ from other treatments for sexually transmitted infections?
Doxycycline is unique because it is a broad-spectrum antibiotic that can be taken orally once or twice daily, making it convenient for patients. Its high tissue penetration and long half-life make it effective against intracellular pathogens, and it is being considered for both treatment and prevention of sexually transmitted infections, especially in light of rising resistance to other antibiotics.
124511Eligibility Criteria
This trial is for men who have sex with men and transgender women to test if taking a doxycycline pill after sexual contact can prevent bacterial STIs. Participants should be willing to provide samples for adherence measurement. The study doesn't include cisgender women due to previous findings.Inclusion Criteria
I am a transgender man using testosterone and my levels show consistent use.
I haven't had an STI in the last 2 years and my partner hasn't had one in the last year.
I am a transgender woman consistently using estrogen hormone therapy.
+3 more
Exclusion Criteria
Doxycycline is detectable in my hair.
Pregnancy or plans to become pregnant
Known hypersensitivity reaction to doxycycline
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants are randomized to different dosing schedules of doxycycline for six weeks
6 weeks
Pharmacokinetic Washout
Doxycycline concentrations are measured in hair, urine, and plasma samples using liquid chromatography tandem mass spectrometry
4 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the effectiveness of a doxycycline pill as post-exposure prophylaxis (PEP) against STIs in high-risk populations. It also aims to develop methods for measuring medication adherence using hair, blood, and urine samples.
4Treatment groups
Active Control
Group I: Daily DosingActive Control1 Intervention
Participants will be randomized to take once daily doxycycline 200mg for six weeks.
Group II: Three-times Weekly DosingActive Control1 Intervention
Participants will be randomized to take one doxycycline 200mg dose three times a week (Monday, Wednesday, and Friday) for six weeks.
Group III: Weekly DosingActive Control1 Intervention
Participants will be randomized to take one doxycycline 200mg dose once week.
Group IV: Every Other Week DosingActive Control1 Intervention
Participants will be randomized to take one doxycycline 200mg dose every other week.
Doxycycline is already approved in United States, European Union, Canada, Japan, Australia for the following indications:
🇺🇸 Approved in United States as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
🇪🇺 Approved in European Union as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
🇨🇦 Approved in Canada as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
🇯🇵 Approved in Japan as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
🇦🇺 Approved in Australia as Doxycycline for:
- Acne
- Bacterial infections
- Chlamydia
- Gonorrhea
- Lyme disease
- Malaria
- Pneumonia
- Rosacea
- Urinary tract infections
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of California, San Francisco/San Francisco General HospitalSan Francisco, CA
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Who Is Running the Clinical Trial?
University of California, San FranciscoLead Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)Collaborator
References
A systematic review of the impacts of oral tetracycline class antibiotics on antimicrobial resistance in normal human flora. [2022]There is interest in doxycycline as prophylaxis against sexually transmitted infections (STIs), but concern about antimicrobial resistance (AMR). We conducted a systematic review (CRD42021273301) of the impact of oral tetracycline-class antibiotics on AMR in normal flora.
Doxycycline in the management of sexually transmitted infections. [2019]Doxycycline is a second-generation tetracycline, available worldwide for half a century. It is an inexpensive broad-spectrum antimicrobial agent largely used in the management of several bacterial infections, particularly involving intracellular pathogens, as well as in the treatment of acne or for the prophylaxis of malaria. Physicochemical characteristics of doxycycline (liposolubility) allow a high diffusion in the tissues and organs. It has high bioavailability and a long elimination half-life allowing oral administration of one or two daily doses. Over the last decade, the prevalence of bacterial sexually transmitted infections (STIs) (syphilis, chlamydiosis, gonorrhoea and Mycoplasma genitalium infections) has increased in most countries, mainly in MSM, many of whom are infected with HIV. In light of increasing prevalence of resistance towards first-line regimens of some STI agents and recently updated recommendations for STI management, doxycycline appears to be an attractive option compared with other available antibiotics for the treatment of some STIs due to its efficacy, good tolerability and oral administration. More recently, indications for doxycycline in STI prophylaxis have been evaluated. Considering the renewed interest of doxycycline in STI management, this review aims to update the pharmacology of, efficacy of, safety of and resistance to doxycycline in this context of use.
Comparison of spiramycin and doxycycline for treatment of Chlamydia trachomatis genital infections. [2021]We performed a single blind controlled multicenter study in which we compared the efficacy and safety of 100 mg of doxycycline versus those of 1 g (3 x 10(6) IU) of spiramycin given orally twice daily for 14 days in the treatment of culture-positive Chlamydia trachomatis genitourinary tract infections. A total of 367 patients were enrolled in the study, and 364 patients were evaluable for safety and 265 patients were evaluable for efficacy. The cure rate between treatment groups was not statistically significant, being 98% (125 of 128 patients) in the spiramycin group and 100% (133 of 133 patients) in the doxycycline group. Female patients who received spiramycin were more likely to report dysethesias that resolved after the completion of therapy. The results of the study show that spiramycin is an effective drug for the treatment of C. trachomatis infection and warrants further assessment over a shorter treatment period (7 days) and during pregnancy.
Doxycycline in the Treatment :uncomplicated Gonorrohea. [2019]Gonorrhoea constitutes nine per cent of the sexually transmitted diseases seen at the department of Dermatology and Venereology, Nair Hospital, Bombay. Fifty cases of uncomplicated males were treated with doxycycline 200mgs iv on the first day and 100 mgs, iv for 2 more - a total of 400 mgs doxycycline. Smears for gonococci and blood V D R L were treatment. The cases were reviewed every week for a period 3 weeks. Three cases showed a positive serology and 44 cases responded well to therapy giving a success rate of 88%. Side effects were minimal.
[Clinical studies on doxycycline in the treatment of nongonococcal urethritis by Chlamydia trachomatis]. [2020]Twenty-one nongonococcal urethritis patients by Chlamydia trachomatis infection were treated with doxycycline (DOXY, Vibramycin) 200 mg/day orally for 2 weeks. The age of these patients were ranged from 17 to 52. C. trachomatis was eradicated 8(89%) of 9 cases on 3rd day and never reisolated on 7th day after treatment. Ten (83%) of 12 patients on 7th day and any patients on 14th day were not suffered from symptoms after treatment. Urethral discharge was not seen macroscopically, 11 (92%) of 12 patients on 7th day and any patients on 14th day. According to the criteria for urethritis requiring at least 4 WBC per high power field in urethral smear and/or first voided urine, the overall clinical efficacy rate was 44% (4/9) on 3rd day, 83% (10/12) on 7th day and 100% (9/9) on 14th day. No side effects were recognized in any cases. In conclusion, DOXY was thought to be useful and safe drug in the treatment of nongonococcal urethritis by C. trachomatis.
Enteric Coating Reduces Upper Gastrointestinal Adverse Reactions to Doxycycline. [2018]A new doxycycline formulation consisting of enteric-coated doxycycline hyclate pellets in capsules is aimed at reducing gastrointestinal adverse reactions related to doxycycline therapy. In this randomised, double-blind, 3-way crossover study, adverse reactions caused by short term treatment with enteric-coated doxycycline hyclate pellets in capsules were compared with placebo and doxycycline monohydrate tablets. The latter are generally considered to be better tolerated than older formulations of doxycycline hyclate. 111 healthy volunteers completed the study. They were given 150mg of doxycycline once daily over 3 consecutive days with a washout of 4 to 10 days between the study periods. The medication was administered after an overnight fast (10 hours) with 200ml of tap water. An upright position was maintained for 1 hour and no food was allowed for 2 hours after drug administration. Participants recorded adverse reactions daily. Adverse reactions were reported by 66% of the subjects during treatment with doxycycline monohydrate, while 43% reported adverse reactions during treatment with enteric-coated doxycycline hyclate and 30% during placebo. Compared with the 2 other groups, doxycycline monohydrate caused significantly more adverse reactions in general, and abdominal pain, nausea and vomiting in particular. It is concluded that enteric-coated doxycycline hyclate pellets in capsules have significantly better gastrointestinal tolerability compared with doxycycline monohydrate.
The use and safety of doxycycline hyclate and other second-generation tetracyclines. [2022]Tetracyclines have long been used to treat a wide variety of medical conditions, especially in the field of dermatology. Unfortunately, safety concerns, especially gastrointestinal (GI), have always been present. Other safety concerns have included tooth development in children, candidiasis, vestibular concerns, photosensitivity/phototoxicity, and more unusual adverse effects such as uncontrolled hypertension. This article first discusses the pharmacological development of the tetracyclines from the first to the second generation versions with an emphasis on the safety concerns, especially with regards to doxycycline hyclate (DH). Second, the adverse effects of the tetracyclines are discussed. Third, the favorable side effect profile of DH delayed release capsules (Doryx) is compared with DH powder contained in tablets (Vibramycin). Fourth, the increased use with a continued favorable safety profile is also discussed concerning the subantimicrobial dosing of DH for acne. Fifth, the safety of periodontic uses of DH is discussed. Last, the favorable safety profiles of the 2006 approved uses of an anti-inflammatory dose of 40 mg doxycycline for rosacea and an extended-release minocycline tablet for acne are also discussed.
[Doxycycline]. [2013]Doxycycline is a semi-synthetic derivative of tetracycline family exhibiting an interesting pharmacokinetic profile since no dosage adjustment is required for renal failure. Doxycycline displays good bacteriostatic activity against most bacteria as well as anti-inflammatory activity. Bacterial resistance is mainly acquired. Many infectious diseases can be treated with doxycycline including brucellosis, pasteurellosis, borreliosis, rickettsioses, trepanomatosis, cholera, leptospirosis, Q fever, pulmonary and urinary infections due to Chlamydia and Mycoplasma, gonococcia, and anthrax. Doxycycline also prevents development of Plasmodium in the blood and is thus useful for malaria prophylaxis. In dermatology, doxycycline is indicated for acnea and rosacea. Doxycycline is well tolerated. The most frequent adverse effects are stomach upset, nausea, and diarrhea, but new formulations that reduce these manifestations are now available. Phototoxicity is dose-dependant and other side effects are rare. Like other tetracylines, doxycycline is contraindicated in children, pregnant women after the second trimester, and breast-feeding mothers.
Interim position statement on doxycycline post-exposure prophylaxis (Doxy-PEP) for the prevention of bacterial sexually transmissible infections in Australia and Aotearoa New Zealand - the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM). [2023]Recent studies have provided evidence for the effectiveness of using doxycycline (Doxy-PEP) to prevent bacterial sexually transmissible infections (STI), namely chlamydia, gonorrhoea, and syphilis, among gay, bisexual, and other men who have sex with men who have experienced multiple STIs. However, there remain several unanswered questions around potential adverse outcomes from Doxy-PEP, including the possibility of inducing antimicrobial resistance in STIs and other organisms, and the possibility of disrupting the microbiome of people who choose to use Doxy-PEP. This interim position statement from the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine aims to outline the current evidence for Doxy-PEP, and to highlight potential adverse outcomes, to enable clinicians to conduct evidence-based conversations with patients in Australia and Aotearoa New Zealand who intend to use Doxy-PEP.
[Clinical and pharmacokinetic researches of doxycyclin vibravenös in childhood (author's transl)]. [2013]Doxycyclin is one of the first efficacious depot antibiotics. It is used in two applications as Vibramycin (R) (peroral and Vibravenös (R) (parenteral). Doxycyclin has a favourable effect not only on different gram-positive and gram-negative bacteria but also on a lot of other germs as mycoplasms, rickettsias, protozoons and large viruses. The tissue invasions is a good one, because there is only a low fraction of free Doxycyclin and further a high lipid activity. Pharmacokinetic investigations of different age-groups show that good serum-levels can be reached because of the sensitivity of numerous germs. The levels are higher, as our experiences demonstrate, if the dose of 4 mg/kilo/weight is injected in two single doses. Our investigations are reported on 49 patients with diseases of the respiratory tract and on 25 patients with diseases of the urogenital tract. Doxycyclin was very useful especially in different forms of pneumonias. The results in infects of the urogenital tract are not so good ones. The compatibility of Doxycyclin can be characterised as very good for children.
Antibiotic after sex could help curb infections. [2022]Doxycycline reduces risk of sexually transmitted diseases-but will it fuel drug resistance?