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In this Randomized Controlled Trial, the investigators will recruit 42 men attending the STI and HIV clinic at the Institute of Tropical Medicine, with a diagnosis of N. gonorrhoeae and randomize them 1:1 to receive either ceftriaxone or ceftriaxone/azithromycin. They will be followed-up for a test of cure visit at day 14 post-treatment where urine, oropharyngeal and anorectal samples will be taken to test for cure and monitor treatment effects on the microbiome and resistome. The primary outcome will be evaluating the difference in the abundance of resistance conferring genes in the rectal microbiome in the two arms, 14 days after the receipt of therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rocephine® | Active Comparator | ceftriaxone 1g + lidocaine 35mg; intramuscular injection |
|
| Rocephine® + Azithromycin | Active Comparator | ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rocephin | Drug | Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Macrolide Resistance Determinants | During the bioinformatic analyses, each identified antibiotic-resistance determinant will be categorized at the class level using a read-based classification tool. The primary outcome will be the ratio of mean macrolide resistance determinants in the day 14 anorectal samples between the two treatment groups. This ratio will be calculated by dividing the mean normalized read count of macrolide- resistance determinants categorized at the class level in the Ceftriaxone/Azithromycin group by the corresponding mean quantity in the Ceftriaxone group. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class | The ratio of mean normalized read count of resistance determinants for each non-macrolide antibiotic class in the day 14 anorectal samples between the two treatment groups | Day 14 |
| Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea |
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Inclusion criteria:
Exclusion criteria:
Inclusion of male sex at birth
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Tropical Medicine | Antwerp | 2000 | Belgium |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rocephine® | ceftriaxone 1g + lidocaine 35mg; intramuscular injection Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection |
| FG001 | Rocephine® + Azithromycin | ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection Azithromycin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rocephine® | ceftriaxone 1g + lidocaine 35mg; intramuscular injection Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection |
| BG001 | Rocephine® + Azithromycin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Macrolide Resistance Determinants | During the bioinformatic analyses, each identified antibiotic-resistance determinant will be categorized at the class level using a read-based classification tool. The primary outcome will be the ratio of mean macrolide resistance determinants in the day 14 anorectal samples between the two treatment groups. This ratio will be calculated by dividing the mean normalized read count of macrolide- resistance determinants categorized at the class level in the Ceftriaxone/Azithromycin group by the corresponding mean quantity in the Ceftriaxone group. | The primary analysis of assessing the ratio between the mean normalized read count of macrolide resistance determinants in anorectal microbiome between the two groups was done using permutation test with 10 000 permutations. | Posted | Mean | 95% Confidence Interval | normalized determinants/million reads | Day 14 |
|
Adverse events and serious adverse events were collected over the whole study duration (4 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rocephine® | ceftriaxone 1g + lidocaine 35mg; intramuscular injection Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Chris Kenyon | Institute of Tropical Medicine Antwerp | +32(0)32470786 | ckenyon@itg.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 3, 2021 | Jun 5, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 9, 2022 | Mar 30, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 3, 2021 | Mar 30, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D002443 | Ceftriaxone |
| D017963 | Azithromycin |
| ID | Term |
|---|---|
| D002439 | Cefotaxime |
| D002505 | Cephacetrile |
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
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| Azithromycin | Drug | Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally |
|
|
The difference in time until acquisition of phenotypic resistance to Azithromycin by N. gonnorrhea in the morbidostat upon exposure to commensal Neisseria DNA extracts from each treatment group |
| Day 0 and Day 14 |
ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally
Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection
Azithromycin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Number | participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| HIV status: Positive | Count of Participants | Participants |
|
| HIV status: Negative | Count of Participants | Participants |
|
| Symptomatic NG | Count of Participants | Participants |
|
| Number of partners (last 3 months) | Median | Inter-Quartile Range | partners |
|
| Use of antibiotics in the last 12 months | Count of Participants | Participants |
|
| Amoxicillin/Clavulanic acid | Count of Participants | Participants |
|
| Ceftriaxone | Count of Participants | Participants |
|
| Doxycycline | Count of Participants | Participants |
|
| Penicillin | Count of Participants | Participants |
|
| PrEP use | Count of Participants | Participants |
|
| Infection site: Anorectal | Count of Participants | Participants |
|
| Infection site: Urethral | Count of Participants | Participants |
|
| Infection site: Pooled | Count of Participants | Participants |
|
| Teeth discoloration | Count of Participants | Participants |
|
| Dental caries | Count of Participants | Participants |
|
Ceftriaxone 1g + lidocaine 35mg intramuscular injection on day 0
| OG001 | Azithromycin / Rocephine® | ceftriaxone 1g + lidocaine 35mg intramuscular injection on day 0 azithromycin 2g per os on day 0 |
|
|
|
| Secondary | Read Count of Resistance Determinants for Each Non-macrolide Antibiotic Class | The ratio of mean normalized read count of resistance determinants for each non-macrolide antibiotic class in the day 14 anorectal samples between the two treatment groups | The normalized macrolide resistance determinants were calculated by dividing the number of macrolide resistance reads by the total number of bacterial reads. The resulting proportion was then multiplied by 106 to present results in normalized determinants per million reads. No sample had a total number of reads below 95 thousand. | Posted | Mean | 95% Confidence Interval | normalized determinants/million reads | Day 14 |
|
|
|
|
| Secondary | Acquisition of Phenotypic Resistance to Azythromycin by N. Gonnorrhea | The difference in time until acquisition of phenotypic resistance to Azithromycin by N. gonnorrhea in the morbidostat upon exposure to commensal Neisseria DNA extracts from each treatment group | change of proportion of isolates resistant to azithromycin between day 0 and day 14 | Posted | Number | Proportion of isolates resistant to AZM | Day 0 and Day 14 |
|
|
|
|
| 0 |
| 22 |
| 0 |
| 22 |
| 2 |
| 22 |
| EG001 | Rocephine® + Azithromycin | ceftriaxone 1g + lidocaine 35mg intramuscular injection + azithromycin 2g orally Rocephin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection Azithromycin: Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally | 0 | 20 | 0 | 20 | 4 | 20 |
| nausea | Gastrointestinal disorders | Systematic Assessment |
|
| pain at injection site | General disorders | Systematic Assessment |
|
| presyncope | Nervous system disorders | Systematic Assessment |
|
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| 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 |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| Bacitracin |
|
| Glycopeptides |
|
| Trimethoprim |
|
| Cationic antimicrobial peptides |
|
| Mupirocin |
|
| Metronidazole |
|
| Fluoroquinolones |
|
| Sulfonamides |
|
| Tetracyclines |
|
| 1 |
| Ratio |
| 1.01 |
| 2-Sided |
| 95 |
| 0.69 |
| 1.44 |
| Superiority |
| For bacitracin | Permutation testing | 1 | Ratio | 3.79 | 2-Sided | 95 | 0.05 | 20.15 | Superiority |
| For glycopeptides | Permutation testing | 1 | Ratio | 0.83 | 2-Sided | 95 | 0 | 1.91 | Superiority |
| For trimethoprim | Permutation testing | 1 | Ratio | 1.19 | 2-Sided | 95 | 0.32 | 3.15 | Superiority |
| For cationic antimicrobial peptides | Permutation testing | 1 | Ratio | 2.82 | 2-Sided | 95 | 0.07 | 14.64 | Superiority |
| For mupirocin | Permutation testing | 1 | Ratio | 1.49 | 2-Sided | 95 | 0 | 5.34 | Superiority |
| For metronidazole | Permutation testing | 1 | Ratio | 1.2 | 2-Sided | 95 | 0 | 3.22 | Superiority |
| For fluoroquinolones | Permutation testing | 1 | Ratio | 6.44 | 2-Sided | 95 | 0.02 | 46.02 | Superiority |
| For sulfonamides | Permutation testing | 1 | Ratio | 10.6 | 2-Sided | 95 | 0.01 | 148.86 | Superiority |
| For tetracyclines | Permutation testing | 0.5621 | Ratio | 1.01 | 2-Sided | 95 | 0.79 | 1.27 | Superiority |
| Commensal Neisseria day 0 |
|
| Commensal Neisseria day 14 |
|
| Superiority |
| For Neisseria | Wilcoxon (Mann-Whitney) | 0.978 | Superiority |
| For Neisseria | Wilcoxon (Mann-Whitney) | 0.184 | Superiority |