SyphilisPhase 4NCT06907316
Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis
A Phase 4 study testing Cefixime 400mg and Benzathine penicillin 2.4 million units in people with Syphilis, run by Bulovka Hospital at 2 sites in Czechia.
Trial summary
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Syphilis
- What is being tested?
- Cefixime 400mg and Benzathine penicillin 2.4 million units
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 2 sitesCzechia
- Study dates
- 13 Jul 2021to 1 Aug 2024
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Non-pregnant, non breastfeeding
- Able to provide informed consent
- Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
- Non-cephalosporin allergic
- Non-penicillin allergic
- Agree to be occasionally called by study staff to be reminded to take study drug
- Willing to attend follow-up visits
Who cannot join
- Under 18 years of age
- Pregnancy, breastfeeding
- Prior history of syphilis in last two years
- Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
- Systemic antibiotic therapy in last two weeks
- Previous enrollment in the study
- Presenting a situation or condition that would not allow reliable study follow up (For example: frequent travel, alcohol abuse or substance misuse)
Trial locations and contacts
2 sites in 1 country.
Czechia2 sites
Národní referenční laboratoř pro syfilis, Státní zdravotní ústav
Prague, 10000
Fakultní nemocnice Bulovka
Prague, 18081
About this study
Official title: Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.
- Conditions
- Syphilis
- Being tested
- Cefixime 400mg, Benzathine penicillin 2.4 million units
- Keywords
- syphilis, treatment, cefixime
- Medical subject headings
- Syphilis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefixime 400mgDrug
cefixime 400 mg taken orally two times a day for 14 consecutive days
Benzathine penicillin 2.4 million unitsDrug
single dose of benzathine penicillin G 2.4 MIU intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| Cefixime | Experimental | cefixime 400 mg taken orally two times a day for 14 consecutive days Receives: Drug: Cefixime 400mg |
| benzathine penicillin G | Active comparator | benzathine penicillin G 2.4 MIU single dose intramuscularly Receives: Drug: Benzathine penicillin 2.4 million units |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serological cure
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
Measured: from baseline (treatment) to 3 months after treatment
Secondary outcomes (2)
Secondary serological cure
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
Measured: from baseline (treatment) to 6 and 12 months after treatment
Treatment safety
Occurrence of treatment-related severe adverse events in treatment groups
Measured: from baseline till the end of follow-up (12 months from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start13 Jul 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Why it stopped: For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyphilisStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulovka Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Všeobecná fakultní nemocnice Praha, Národní referenční laboratoř pro syfilis, Státní zdravotní ústav, Örebro University, Sweden
- Responsible party
- Principal investigator, Filip Rob MD, PhD, Bulovka Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907316
- Sponsor's protocol ID
- 1.6.2021/10071/EK-Z
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cefixime Versus Benzathine Penicillin G in Treatment of Early Syphilis - a Randomized, Multicentre, Non-inferiority, Open Label Trial
- ClinicalTrials.gov ID
- NCT06907316
- Acronym / sponsor ID
- 1.6.2021/10071/EK-Z
- Conditions
- Syphilis
- Keywords
- syphilis, treatment, cefixime
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Bulovka HospitalUniversity, hospital or other
- Collaborators
- Všeobecná fakultní nemocnice Praha, Národní referenční laboratoř pro syfilis, Státní zdravotní ústav, Örebro University, Sweden
- Study start
- 13 Jul 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 2 Apr 2025 (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.
This study evaluates the efficacy (non-inferiority) and safety of a new antibiotic treatment (cefixime), which has been previously used for single dose therapy of gonorrhoea in many years , in the treatment of early syphilis. Participants will be randomized to one of two study arms and will receive either expirimental regimen (cefixime) or the current standard antibiotic regimen (benzathine penicillin G). New treatment alternatives for syphilis could ensure that people are appropriately treated during periods or in settings of benzathine penicillin G stock out, penicillin allergy, or other intolerance to penicillin injection. This study may also identify an oral regimen for settings in which injections are not feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefixime | Experimental | Drug: Cefixime 400mgcefixime 400 mg taken orally two times a day for 14 consecutive days |
| benzathine penicillin G | Active comparator | Drug: Benzathine penicillin 2.4 million unitsbenzathine penicillin G 2.4 MIU single dose intramuscularly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- Non-pregnant, non breastfeeding
- Able to provide informed consent
- Clinically or laboratory-confirmed primary, secondary or early latent syphilis with a positive rapid treponemal test and an RPR/VDRL titer equal to or greater than 1:8
- Non-cephalosporin allergic
Key exclusion criteria (7 listed)
- Under 18 years of age
- Pregnancy, breastfeeding
- Prior history of syphilis in last two years
- Allergy or contraindication to penicillin or cephalosporins (including allergy to cefixime)
- Systemic antibiotic therapy in last two weeks
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 |
|---|---|---|
| Cefixime 400mgcefixime 400 mg taken orally two times a day for 14 consecutive days | Drug | Cefixime |
| Benzathine penicillin 2.4 million unitssingle dose of benzathine penicillin G 2.4 MIU intramuscularly | Drug | benzathine penicillin G |
Primary outcome
Serological cure
Time frame: from baseline (treatment) to 3 months after treatment
a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer
2 secondary outcomes
Secondary serological cure
Time frame: from baseline (treatment) to 6 and 12 months after treatment
Treatment safety
Time frame: from baseline till the end of follow-up (12 months from baseline)
Results and safety
The study was stopped early (reason given: For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cefixime 400mg and Benzathine penicillin 2.4 million units in people with Syphilis, run by Bulovka Hospital at 2 sites in Czechia.
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 8 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Czechia. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.). Results are not available in the source record.
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.
What does the primary outcome measure?
Serological cure (time frame: from baseline (treatment) to 3 months after treatment). 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 2 Apr 2025.