Ciprofloxacin BioThrax Co-Administration Study



Status:Completed
Conditions:Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 45
Updated:7/16/2013
Start Date:December 2012
End Date:May 2013

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A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults


The purpose of this clinical trial is to determine whether there is any effect on the
antibiotic, ciprofloxacin when taken before and after administration of a 3-dose series of
BioThrax.

This study will be conducted in the United States (US) in 120 healthy male and female
volunteer subjects ages 18 to 45.

The duration of study participation for each subject will be approximately 76 days
(approximately 2.5 months)


BioThrax® (also called Anthrax Vaccine Adsorbed or AVA) is the only FDA-licensed vaccine for
the prevention of anthrax infection. This is a randomized, open-label, Phase 2,
multi-center trial to investigate the potential interactions of ciprofloxacin (Cipro) and
BioThrax.

Inclusion Criteria:

- Be between 18 and 45 years of age, at the time of enrollment

- Be in good health as determined by the investigator from medical history and a
physical examination.

- If a pre-menopausal female, must be using acceptable methods of birth control.

- Be willing and able to return for all follow-up visits and blood and urine
collections for the duration of the trial

- Be willing and able to complete a web-enabled electronic diary and report concomitant
medications, adverse events, and BioThrax reactogenicity events during the trial

- Be able to understand and communicate in English.

Exclusion Criteria:

- Prior immunization with anthrax vaccine or known exposure to anthrax organisms

- Intend to enlist in the military during the study.

- Have a known allergy to aluminum hydroxide, formaldehyde, benzethonium chloride, or
latex.

- Plan to receive experimental products 30 days prior to study entry or at any time
during the study

- Have received a live vaccine in the 30 days before study entry

- Plan to receive a live vaccine at any time during the study.

- Have ongoing drug abuse/dependence (including alcohol) issues and/or test positive in
a urine drug screen for amphetamines, barbiturates, cocaine or opiates

- Have received immunosuppressive therapy (including systemic steroids) within 30 days
prior to trial entry

- Have any other condition known to produce or be associated with immunosuppression

- Have received cytotoxic therapy in the previous 5 years

- A chronic condition that, in the opinion of the Investigator, would render
vaccination unsafe or would interfere with trial evaluations or completion of the
study.
We found this trial at
3
sites
Omaha, Nebraska 68134
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Omaha, NE
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1010 Carondelet Drive
Kaw, Missouri 64114
816-943-0770
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from
Kaw, MO
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9 Medical Parkway
Northeast, Texas 75234
281-579-1938
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from
Northeast, TX
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