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For financial and personnel reasons, patient recruitment was carried out in only one of the planned centers.
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| Name | Class |
|---|---|
| Všeobecná fakultní nemocnice Praha | UNKNOWN |
| Národní referenční laboratoř pro syfilis, Státní zdravotní ústav | UNKNOWN |
| Örebro University, Sweden | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cefixime | Experimental | cefixime 400 mg taken orally two times a day for 14 consecutive days |
|
| benzathine penicillin G | Active Comparator | benzathine penicillin G 2.4 MIU single dose intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cefixime 400mg | Drug | cefixime 400 mg taken orally two times a day for 14 consecutive days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Serological cure | a 4-fold or more (≥2 dilution steps) decrease in rapid plasma reagin (RPR) or veneral disease reach laboratory test (VDRL) titer | from baseline (treatment) to 3 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline (treatment) to 6 and 12 months after treatment |
| Treatment safety |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Národní referenční laboratoř pro syfilis, Státní zdravotní ústav | Prague | 10000 | Czechia | |||
| Fakultní nemocnice Bulovka |
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| ID | Term |
|---|---|
| D013587 | Syphilis |
| ID | Term |
|---|---|
| D014211 | Treponemal Infections |
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
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| ID | Term |
|---|---|
| D020682 | Cefixime |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Benzathine penicillin 2.4 million units |
| Drug |
single dose of benzathine penicillin G 2.4 MIU intramuscularly |
|
Occurrence of treatment-related severe adverse events in treatment groups
| from baseline till the end of follow-up (12 months from baseline) |
| Prague |
| 18081 |
| Czechia |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D015231 | Sexually Transmitted Diseases, Bacterial |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007769 |
| Lactams |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |