Ciprofloxacin BioThrax Co-Administration Study
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Purpose
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)
| Condition | Intervention | Phase |
|---|---|---|
|
Anthrax |
Biological: BioThrax Drug: Ciprofloxacin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Study of The Effects of Co-Administering Ciprofloxacin and BioThrax on the Pharmacokinetics of Ciprofloxacin in Healthy Adults |
- Ciprofloxacin area under the curve [ Time Frame: predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, and 12 hours postdose on Days 1, 5, 40, and 44 in Arm 1. ] [ Designated as safety issue: No ]Area under the curve from zero to 12 hours (AUC0-12h) and maximum concentration (Cmax) achieved for ciprofloxacin
- Immunogenicity [ Time Frame: Days 1 and Day 48 (Arms 1 and 2); Days 1 and 43 (Arm 3) ] [ Designated as safety issue: No ]Toxin Neutralizing Antibody (TNA) levels expressed as Geometric Mean Titer (GMT) 2 weeks after last vaccination.
- Safety and tolerability, as evaluated by adverse events and clinical laboratory tests [ Time Frame: Up to 48 days ] [ Designated as safety issue: Yes ]Monitoring treatment emergent adverse events (TEAEs), Serious adverse events (SAEs) and clinically significant changes in laboratory parameters from Day 0 to 48 (Arms 1 and 2) or from Day 0 to 43 (Arm 3)
| Estimated Enrollment: | 120 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: BioThrax + Ciprofloxacin PK |
Biological: BioThrax
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Other Names:
Drug: Ciprofloxacin
500 mg twice a day
Other Name: Cipro
|
| Experimental: BioThrax + Ciprofloxacin no PK |
Biological: BioThrax
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Other Names:
Drug: Ciprofloxacin
500 mg twice a day
Other Name: Cipro
|
| Experimental: BioThrax only |
Biological: BioThrax
route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
Other Names:
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| United States, Missouri | |
| The Center for Pharmaceutical Research | Recruiting |
| Kansas City, Missouri, United States, 64114 | |
| Contact: John Irvin, MD 816-943-0770 missy@cprkc.com | |
| Principal Investigator: John Ervin, MD | |
| United States, Nebraska | |
| Meridian Clinical Research | Recruiting |
| Omaha, Nebraska, United States, 68134 | |
| Contact: Brandon Essink, MD 402-933-6500 lfalcone@meridianclinicalresearch.com | |
| Principal Investigator: Brandon Essink, MD | |
| United States, Texas | |
| Research Across America | Recruiting |
| Dallas, Texas, United States, 75234 | |
| Contact: Joe Blumenau, MD 763-208-8199 mlapage@RAASites.com | |
| Principal Investigator: Joe Blumenau, MD | |
| Principal Investigator: | Robert Hopkins, MD, MPH, TM | Emergent BioSolutions Inc. |
More Information
No publications provided
| Responsible Party: | Emergent BioSolutions |
| ClinicalTrials.gov Identifier: | NCT01753115 History of Changes |
| Other Study ID Numbers: | EBS.AVA.009 |
| Study First Received: | December 14, 2012 |
| Last Updated: | December 19, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Emergent BioSolutions:
|
post-exposure prophylaxis toxin neutralization assay |
Additional relevant MeSH terms:
|
Anthrax Bacillaceae Infections Gram-Positive Bacterial Infections Bacterial Infections Ciprofloxacin Nucleic Acid Synthesis Inhibitors |
Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Infective Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013