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 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.

A Comparison of Spectinomycin with Ceftriaxone as Treatment for Uncomplicated Gonorrhea

“…17 On occasion, spectinomycin-resistant isolates were found in samples from the United States, India, and China, according to a study by Bala et al & Nguyen et al that was published in 2005. 18 , 24 According to our findings, 95% of patients were susceptible to spectinomycin, whereas 6% were resistant. In 6% of patients, resistance to spectinomycin exists in either a partial (3%) or complete (2%) form.…”

The Effect of Amoxicillin Pre-Exposure on Treatment Outcomes and Antimicrobial Susceptibility in Patients with Urogenital Chlamydia trachomatis Infection

“… 43 CT and NG are common bacterial causes of sexually transmitted diseases with high incidence of co-infection in urogenital tracts. 44 Also, the t et (M) gene was found in most of the tetracycline-resistant NG isolates. 45 , 46 Mycoplasma hominis (MH) is an opportunistic pathogen detected on the mucosal membranes of human urogenital tracts.…”

Current Susceptibility Surveillance and Distribution of Antimicrobial Resistance in N. gonorrheae within WHO Regions

“…Extensive studies and clinical trials were only done for gentamicin, but its efficacy has proven to be sub-optimal, particularly for pharyngeal infections. Importantly, in a recent study of the relative efficacy of high-dose intravenous ceftriaxone and oral cefixime combined with doxycycline for treatment of the frequently seen and sexually transmittable Chlamydia trachomatis and Neisseria gonorrhoeae co-infection, the combination of doxycycline with ceftriaxone was indicated as superior to its combination with cefixime, and cefixime with doxycycline was recommended only in patients with ceftriaxone allergy and in settings where ceftriaxone is unavailable [50]. Of the already approved therapeutics, the most promising seems to be ertapenem.…”