Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection
Abstract Objectives Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the commonest bacterial causes of sexually transmitted infections in humans with high incidence of co-infection. Treatment with high doses of ceftriaxone (CRO) and cefixime (CFM) is strongly recommended due to the redu...
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| Format: | Article |
| Language: | English |
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BMC
2022-07-01
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| Series: | BMC Infectious Diseases |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s12879-022-07595-w |
| _version_ | 1811219016570634240 |
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| author | Phuong Thi Thu Nguyen Ha Viet Pham Dung Hoang Van Linh Van Pham Hoi Thanh Nguyen Hung Van Nguyen |
| author_facet | Phuong Thi Thu Nguyen Ha Viet Pham Dung Hoang Van Linh Van Pham Hoi Thanh Nguyen Hung Van Nguyen |
| author_sort | Phuong Thi Thu Nguyen |
| collection | DOAJ |
| description | Abstract Objectives Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the commonest bacterial causes of sexually transmitted infections in humans with high incidence of co-infection. Treatment with high doses of ceftriaxone (CRO) and cefixime (CFM) is strongly recommended due to the reduced drug susceptibility of NG. However, their safety and efficacy have not been confirmed. We compared the safety and efficacy of a single 1 g intravenous (IV) dose of ceftriaxone (CRO) plus doxycycline (DOX) versus a single 800 mg oral dose of cefixime (CFM) plus DOX for the treatment of NG-CT co-infection. Methods An open-label randomized controlled trial was conducted on 125 individuals aged > 18 years with untreated gonorrhea and chlamydia to compare a single 1 g intravenous dose of CRO + DOX and a single 800 mg oral dose of CFM + DOX. The primary outcome was the clearance of NG from all the initially infected sites. Secondary outcomes included symptom resolution, changes in the serum clearance levels, glomerular filtration rate, and antibiotic minimum inhibitory concentrations. Results Both regimens were highly effective in treating gonorrhea with success rates of 96.7% (95% confidence interval [CI] 88.8–99.1%) for CRO and 95.3% (95% CI 87.1–98.4%) for CFM. However, CRO + DOX was superior to CFM + DOX for the treatment of NG-CT co-infection (odds ratio 4.41, 95% CI 1.11–25.7). The safety profiles of the two regimens were similar. Conclusions CRO + DOX was superior to CFM + DOX for the treatment of NG-CT co-infection. CFM + DOX may be indicated in patients with CRO allergy and in settings where CRO is unavailable. Trial registration ClinicalTrials.gov (NCT05216744) on 31/01/22. |
| first_indexed | 2024-04-12T07:18:39Z |
| format | Article |
| id | doaj.art-cb724b3c0e8f43f28cebb596ac189524 |
| institution | Directory Open Access Journal |
| issn | 1471-2334 |
| language | English |
| last_indexed | 2024-04-12T07:18:39Z |
| publishDate | 2022-07-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Infectious Diseases |
| spelling | doaj.art-cb724b3c0e8f43f28cebb596ac1895242022-12-22T03:42:23ZengBMCBMC Infectious Diseases1471-23342022-07-012211910.1186/s12879-022-07595-wRandomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infectionPhuong Thi Thu Nguyen0Ha Viet Pham1Dung Hoang Van2Linh Van Pham3Hoi Thanh Nguyen4Hung Van Nguyen5Hai Phong University of Medicine and PharmacyHai Phong International HospitalHai Phong University of Medicine and PharmacyHai Phong University of Medicine and PharmacyHai Phong University of Medicine and PharmacyHai Phong University of Medicine and PharmacyAbstract Objectives Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the commonest bacterial causes of sexually transmitted infections in humans with high incidence of co-infection. Treatment with high doses of ceftriaxone (CRO) and cefixime (CFM) is strongly recommended due to the reduced drug susceptibility of NG. However, their safety and efficacy have not been confirmed. We compared the safety and efficacy of a single 1 g intravenous (IV) dose of ceftriaxone (CRO) plus doxycycline (DOX) versus a single 800 mg oral dose of cefixime (CFM) plus DOX for the treatment of NG-CT co-infection. Methods An open-label randomized controlled trial was conducted on 125 individuals aged > 18 years with untreated gonorrhea and chlamydia to compare a single 1 g intravenous dose of CRO + DOX and a single 800 mg oral dose of CFM + DOX. The primary outcome was the clearance of NG from all the initially infected sites. Secondary outcomes included symptom resolution, changes in the serum clearance levels, glomerular filtration rate, and antibiotic minimum inhibitory concentrations. Results Both regimens were highly effective in treating gonorrhea with success rates of 96.7% (95% confidence interval [CI] 88.8–99.1%) for CRO and 95.3% (95% CI 87.1–98.4%) for CFM. However, CRO + DOX was superior to CFM + DOX for the treatment of NG-CT co-infection (odds ratio 4.41, 95% CI 1.11–25.7). The safety profiles of the two regimens were similar. Conclusions CRO + DOX was superior to CFM + DOX for the treatment of NG-CT co-infection. CFM + DOX may be indicated in patients with CRO allergy and in settings where CRO is unavailable. Trial registration ClinicalTrials.gov (NCT05216744) on 31/01/22.https://doi.org/10.1186/s12879-022-07595-wChlamydia trachomatisNeisseria gonorrhoeaeCeftriaxoneCefiximeCo-infection |
| spellingShingle | Phuong Thi Thu Nguyen Ha Viet Pham Dung Hoang Van Linh Van Pham Hoi Thanh Nguyen Hung Van Nguyen Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection BMC Infectious Diseases Chlamydia trachomatis Neisseria gonorrhoeae Ceftriaxone Cefixime Co-infection |
| title | Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection |
| title_full | Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection |
| title_fullStr | Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection |
| title_full_unstemmed | Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection |
| title_short | Randomized controlled trial of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of Chlamydia trachomatis and Neisseria gonorrhoeae co-infection |
| title_sort | randomized controlled trial of the relative efficacy of high dose intravenous ceftriaxone and oral cefixime combined with doxycycline for the treatment of chlamydia trachomatis and neisseria gonorrhoeae co infection |
| topic | Chlamydia trachomatis Neisseria gonorrhoeae Ceftriaxone Cefixime Co-infection |
| url | https://doi.org/10.1186/s12879-022-07595-w |
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