A Randomized study to Compare the Efficacy of Single Dose Oral Azithromycin Versus Injection Benzathine Penicillin G in the Treatment of Early Syphilis in a Tertiary Care Hospital in South India

Guru, R (2021) A Randomized study to Compare the Efficacy of Single Dose Oral Azithromycin Versus Injection Benzathine Penicillin G in the Treatment of Early Syphilis in a Tertiary Care Hospital in South India. Masters thesis, Stanley Medical College, Chennai.


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INTRODUCTION: The current recommended therapy for the treatment of early syphilis is a single dose of injection Benzathine Penicillin G, widely preferred because of its low cost and absence of problems related to poor adherence. But as with most parenteral therapies, it has the disadvantages of relatively high prevalence of anaphylactic reactions, pain associated with large volume, deep, intramuscular injections. Most of these disadvantages can be overcome with the introduction of an effective and well tolerated oral drug. A promising candidate is the macrolide antibiotic, Azithromycin which has a long half-life and proven efficacy against other sexually transmitted organisms like Chlamydia trachomatis, Neisseria gonorrhoeae and Hemophilus ducreyi. It has also been suggested in two pilot studies that the drug may be effective in preventing syphilis in persons exposed to infectious cases and in treating early syphilis AIM OF THE STUDY: To compare the efficacy of single dose oral azithromycin versus injection Benzathine Penicillin G in the treatment of early syphilis. OBJECTIVES: To establish an effective, safe and oral alternative drug that can overcome the disadvantages associated with parenteral therapy in the treatment of early syphilis METHODOLOGY: Randomized, comparative and Interventional study was undertaken in Department of Venerology Govt Stanley Medical College from April 2019-March 2020 dividing the participants into two groups. Group A: Participants will receive single dose of Inj. Benzathine Penicillin G 2.4 million units, deep IM, (given half – 1.2 million units- over each buttock) after test dose. Group B: Participants will receive single dose of Tab. Azithromycin 2g Orally. The patients were then followed up after 1 week and then at 2 weeks for clinical improvement with serial photographs taken. Then every 1 month for the next 3 months and at 6th month. At each follow-up examination, participants were asked to report any sexual exposure between visits and clinically evaluated for persistent or recurrent syphilis. A 2-ml blood sample obtained for serologic analysis for syphilis at each visit. RESULTS: Among those belonging to penicillin group all (100%) of them showed clinical improvement compared to almost all (96%) belonging to azithromycin group and there was no statistical significance between the two groups. At the end of 6 months, 6 patients reverted to become non-reactive, whereas 2 patients became 1:1 dilution in penicillin group, compared to 0 (non-reactive) and 5 (1:1) dilution in azithromycin group. Though there is a decline from baseline in both the groups, the penicillin group showed a much more effective decline compared to the azithromycin group. CONCLUSION: Penicillin is the only antibiotic currently recommended for primary and secondary syphilis in non-penicillin allergic patients. The antimicrobial spectrum and long half-life of the azithromycin suggest its usage to treat syphilis Also, no major side-effects were noted in both the study groups. Still many more studies with large sample size and varied drug dosage are needed to show potential of azithromycin to replace penicillin in practice.

Item Type: Thesis (Masters)
Additional Information: 201830054
Uncontrolled Keywords: Efficacy, Single Dose Oral Azithromycin, Injection Benzathine Penicillin G Treatment, Early Syphilis, Tertiary Care Hospital, South India.
Subjects: MEDICAL > Dermatology Venereology and Leprosy
Depositing User: Subramani R
Date Deposited: 20 Oct 2021 15:42
Last Modified: 06 Mar 2022 04:40
URI: http://repository-tnmgrmu.ac.in/id/eprint/18599

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