Syphilis Female Clinical Trial
Official title:
Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis in Non-pregnant Women
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will
be efficacious and safe.
Primary Objective The primary objective of the study is to demonstrate the efficacy, as
measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months
after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.
Secondary Objective The secondary objective of the study is to determine the safety, as
measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI
toxicity score, during or after treatment with Cefixime 400mg taken orally two times a day
for 10 consecutive days.
Hypotheses The antibiotic, Cefixime, for use in non-pregnant women with early syphilis will
be efficacious and safe.
Primary Objective The primary objective of the study is to demonstrate the efficacy, as
measured by a 4 fold decrease in Rapid Plasma Reagin (RPR) titer from baseline to 6 months
after treatment, with Cefixime 400mg taken orally two times a day for 10 consecutive days.
Secondary Objective The secondary objective of the study is to determine the safety, as
measured by the number of grade 3 or greater toxicities experienced, using the NIH/NCI
toxicity score (10), during or after treatment with Cefixime 400mg taken orally two times a
day for 10 consecutive days.
Methods Study design This is a randomized, non-comparative, open-label study assessing the
efficacy and safety of cefixime 400mg taken orally two times a day for 10 consecutive days in
non-pregnant women with early syphilis infection.
Study population and enrolment sites Numerous regions of Brazil have experienced increases in
syphilis diagnoses during the previous 5 years The study sites were chosen from three cities
in three separate regions (states) of Brazil based on: (1) increases in syphilis case
reports, (2) access to clinics where patients are screened and treated for syphilis; (3)
willingness of clinic sites and staff to participate in this research, and (4) the
availability of experienced researchers with experience in studying syphilis to serve as
co-investigators.
The study population will include non-pregnant women (ages 18 and over) diagnosed with early
syphilis (RPR titers >1:8) recruited from 7 clinics in three cities from three states in
Brazil. These include: (1) Three clinics in the city of Fortaleza (Ceara State), coordinated
by the University of Fortaleza (UNIFOR): (a) Carlos Ribeiro, (a) Meireles, and (c) Federal
University. Syphilis epidemiology for each site in Annex 1. (2) Two University ObGyn Clinics
in the city of Pelotas (state of Rio Grande do Sul) (5-6 cases of syphilis/week) a)
Ambulatorio de Ginecologia e Obstetrícia - Faculdade de Medicina - Universidade Federal de
Pelotas and b) Ambulatorio de Ginecologia e Obstetrícia - Campus da Saúde - Universidade
Católica de Pelotas; and (3) Two clinics in Vitoria (State of Espirito Santo): (1) Reference
Center for Sexually Transmitted Diseases
(http://www.vitoria.es.gov.br/cidadao/centro-de-referencia-em-infeccoes-sexualmente-transmiss
iveis). (2) Hospital Universitário Cassiano Antonio Moraes - UFES.
Patients identified during standard of care testing with a positive rapid syphilis test and
an RPR titer of greater than or equal to 1:8 will be referred to the study and offered
enrollment according to the following description.
Non-study clinic-site staff will perform the first screening rapid finger-stick test for
syphilis. The rapid syphilis test currently used in these clinics detects both new (acute)
infection and old treated infection but does not distinguish between the two. Patients that
are positive for the syphilis rapid finger-stick test will be notified by non-study staff of
this result and the need for additional testing using the RPR test according to standard of
care. Blood will be collected for the confirmatory RPR test by non-study staff. These
patients will be notified of RPR results in approximately 3 days to 1 week. The results a
confirmed syphilis diagnosis and of the RPR test results for those patients that are eligible
for enrolment in the study (RPR >1:8) will be provided by a study nurse. The study will be
explained to eligible participants (RPR titer of >1:8) by this study nurse, and if women
express interest in participating, informed consent will be obtained. It is expected that an
enrolment visit could last approximately 1.5 hours.
Patients that are not eligible for the study (negative RPR or RPR with titer <1:8) will
receive syphilis RPR results from non-study staff.
Pregnancy tests will be completed on all potential participants and those that test positive
will not be enrolled in the study.
The timing of the recruitment process will depend on the number of women diagnosed with
syphilis and who have an RPR titer >1:8 and who consent to participate in the study. It is
anticipated that enrollment will take approximately 1 year to complete.
To benchmark the performance of benzathine penicillin in the study population being used for
cefixime, The investigators will include a contemporary arm of participants that will receive
standard of care treatment with benzathine penicillin according to the Brazil national
sexually transmitted infection (STI) treatment guidelines. The investigators will use a ratio
of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.
This non-comparator arm of benzathine penicillin will be included to account for study
population differences in terms of stage of disease, history of prior infection, experience
of re-infection, experience of serofast state, or other co-factors that could impact
serological response. An estimate of performance of this standard of care will be calculated,
but this will not be compared directly to the study intervention.
The investigators will enrol 180 eligible women into the study: 120 for the cefixime arm and
60 for the benzathine penicillin arm. It is anticipated that enrollment will take
approximately 1 year to complete. Patients will be participating in the study for
approximately 9 months. The study is expected to last for approximately two years. Women that
are referred to the study but decline enrolment will be treated at the clinic following
national STI treatment guidelines for syphilis.
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