GonorrhoeaPhase 1NCT02708992
Cefixime / Azithromycin pK Study
A Phase 1 study testing Azithromycin and Cefixime in people with Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Gonorrhoea
- What is being tested?
- Azithromycin and Cefixime
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2016to 31 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Healthy male or female subjects between 18 and 45 years, inclusive 2. Ability to understand the consent process and procedures 3. Informed consent obtained and signed prior to initiation of any study procedures 4. Subjects agree to be available for all study visits 5. Negative breathalyzer for alcohol 6. Agreement by female subjects with reproductive potential to use an adequate method of contraception during the study and for 30 days after last study drug administration. Female subjects must agree to the use of TWO reliable methods of contraception while receiving study drug and for 30 days after last study drug administration if sexually active, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill (OCP), and depot progesterone injections.
Who cannot join
- 1. Subjects who take any prescription medication on a regular basis (except OCPs), including but not limited to, anti-psychotics, anti-depressants, anti-epileptics, cardiac medications, and antihypertensives. 2. Subjects who take any OTC drugs or herbal remedies on a regular basis, especially those that have been associated with a risk of QT prolongation such as antiemetics (ondansetron, granisetron, dolasetron, hydroxyzine), antihistamines (terfenadine, astemizole, hydroxyzine, diphenhydramine), GI stimulants (cisapride, domperidone, metoclopramide), and homeopathic agents (cinchona, licorice extract- glycyrrhizin). 3. Hypertension with confirmed systolic blood pressure >140 mmHg or confirmed diastolic blood pressure > 90 mmHg, measured after 10 to 15 minutes of rest 4. Morbid obesity (BMI >/= 35 kg/m^2) 5. Current diagnosis of pulmonary disease 6. History or current diagnosis of diabetes 7. Autoimmune disorders, such as lupus, Wegener's, rheumatoid arthritis 8. History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma thought to be cured) 9. Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure 10. History of alcohol abuse 11. History of seizure disorder 12. History of renal disease 13. Chronic renal, hepatic, or pulmonary disease or other condition that could interfere with the absorption of the study drug or predispose to adverse GI events (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease) 14. Positive serology results for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies 15. Subjects who have taken any prescription drugs in the previous 14 days or within five half-lives before dosing 16. Ingestion of OTC medications or herbal supplements within seven days of dosing 17. Positive urine drug screen for marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, or benzodiazepines 18. History of allergic reaction or intolerance to cephalosporins 19. History of allergic reaction to penicillin (all stages) 20. History of allergic reaction to azithromycin, erythromycin, or any macrolide or ketolide antibiotic 21. History of jaundice or hepatic dysfunction associated with prior use of azithromycin 22. Males with a QTcF > 430ms or Females with a QTcF >450ms (Fridericia's correction) on screening 23. Positive pregnancy test; pregnant or nursing women 24. Screening laboratory tests > Grade 1 as defined by Appendix B 25. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University School of Medicine - Duke Clinical Research Institute - Duke Clinical Research Unit
Durham, North Carolina, 27710-4000
About this study
Official title: The Pharmacokinetics of Extended Duration High-Dose Cefixime Co-administered With Azithromycin for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800
Read the detailed description
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800 mg cefixime given on a q 8-hour schedule. The primary safety objectives are to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime; to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime co-administered with a single 1000 mg dose of azithromycin. The study will take place for 10 weeks.
- Conditions
- Gonorrhoea
- Being tested
- Azithromycin, Cefixime
- Keywords
- Azithromycin, Cefixime, Duration, High-Dose, Neisseria gonorrhoeae, Pharmacokinetics, Susceptibility
- Medical subject headings
- Gonorrhea, Disease Susceptibility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AzithromycinDrug
CefiximeDrug
| Study group | Role | What they receive |
|---|---|---|
| Cefixime/Azithromycin | Experimental | Eight participants will receive three oral doses of 800 mg cefixime (q 8 hours) on Day 1, followed by three oral doses of 800 mg cefixime (q 8 hours)+ one oral dose of 1000 mg azithromycin (with first dose of cefixime) on day 10 Receives: Drug: Azithromycin; Drug: Cefixime |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC from 0 to infinity [AUC0-infinity]
Measured: Day 1,2,3,10,11,12 and at early termination
Averaged composite plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Measured: Day 1,2,3,10,11,12 and at early termination
Elimination half-life (t1/2)
Measured: Day 1,2,3,10,11,12 and at early termination
Elimination rate (lambda z)
Measured: Day 1,2,3,10,11,12 and at early termination
Individual plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Measured: Day 1,2,3,10,11,12 and at early termination
Peak cefixime level (Cmax)
Measured: Day 1,2,3,10,11,12 and at early termination
Safety blood test results
Measured: Day: -28,-1, 2, 3, 9, 11, 12, 17 and at early termination
Safety urinanalysis results
Measured: Day: -28, -1, 2, 3, 9, 11, 12, 17 and at early termination
Subject reported AEs
Measured: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Subject reported serious adverse events (SAEs)
Measured: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Targeted clinical evaluations
Measured: Day: -1,1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Time that cefixime levels exceed four times the MIC of 0.5 mcg/mL (i.e., a plasma level of 2.0 mcg/mL)
Measured: Day 1,2,3,10,11,12 and at early termination
Time to peak drug level (Tmax)
Measured: Day 1,2,3,10,11,12 and at early termination
Total area under the curve (AUC from 0 hours to the time of next dosing [AUC0-t])
Measured: Day 1,2,3,10,11,12 and at early termination
Total plasma concentrations of cefixime
Measured: Day 1,2,3,10,11,12 and at early termination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start28 Apr 2016
- Primary completion31 Dec 2016
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GonorrhoeaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708992
- Sponsor's protocol ID
- 15-0031
- Other IDs
- HHSN272201500006I
- Status last verified
- 19 Jul 2017
- First submitted
- 10 Mar 2016
- Last updated
- 15 Sep 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pharmacokinetics of Extended Duration High-Dose Cefixime Co-administered With Azithromycin for the Decreased Susceptibility of Neisseria Gonorrhoeae: A Phase I Pilot Study
- ClinicalTrials.gov ID
- NCT02708992
- Acronym / sponsor ID
- 15-0031
- Conditions
- Gonorrhoea
- Keywords
- Azithromycin, Cefixime, Duration, High-Dose, Neisseria gonorrhoeae, Pharmacokinetics, Susceptibility
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 15 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800
Detailed description
This is a PK study of a multi-dose oral cefixime regimen (three 800 mg doses given on a q 8-hour schedule) alone and also co administered with a single 1000 mg oral dose of azithromycin, both within a 24-hour period, in order to achieve total serum cefixime levels of mcg/mL for at least 20 hours. This will determine the tolerability of the regimen and whether there are significant changes in cefixime PK after co-administration. The primary pharmacokinetic objectives are: to determine if a cefixime dosing regimen of three 800 mg doses given alone, on a q 8-hour schedule achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; to determine if a cefixime dosing regimen of three 800 mg doses given on a q 8 hour schedule co-administered with a single 1000 mg of azithromycin, achieves a total serum cefixime level that exceeds 2.0 mcg/mL for at least 20 hours; and to evaluate whether a single 1000 mg dose of azithromycin alters the PK of a three dose regimen of 800 mg cefixime given on a q 8-hour schedule. The primary safety objectives are to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime; to assess the safety and tolerability of a treatment regimen that includes three doses of 800 mg cefixime co-administered with a single 1000 mg dose of azithromycin. The study will take place for 10 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefixime/Azithromycin | Experimental | Drug: Azithromycin, Drug: CefiximeEight participants will receive three oral doses of 800 mg cefixime (q 8 hours) on Day 1, followed by three oral doses of 800 mg cefixime (q 8 hours)+ one oral dose of 1000 mg azithromycin (with first dose of cefixime) on day 10 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Healthy male or female subjects between 18 and 45 years, inclusive 2. Ability to understand the consent process and procedures 3. Informed consent obtained and signed prior to initiation of any study procedures 4. Subjects agree to be available for all study visits 5. Negative breathalyzer for alcohol 6. Agreement by female subjects with reproductive potential to use an adequate method of contraception during the study and for 30 days after last study drug administration. Female subjects must agree to the use of TWO reliable methods of contraception while receiving study drug and for 30 days after last study drug administration if sexually active, which can include: condoms, spermicidal gel, diaphragm, hormonal or non-hormonal intrauterine device, surgical sterilization, oral contraceptive pill (OCP), and depot progesterone injections.
Key exclusion criteria (1 listed)
- 1. Subjects who take any prescription medication on a regular basis (except OCPs), including but not limited to, anti-psychotics, anti-depressants, anti-epileptics, cardiac medications, and antihypertensives. 2. Subjects who take any OTC drugs or herbal remedies on a regular basis, especially those that have been associated with a risk of QT prolongation such as antiemetics (ondansetron, granisetron, dolasetron, hydroxyzine), antihistamines (terfenadine, astemizole, hydroxyzine, diphenhydramine), GI stimulants (cisapride, domperidone, metoclopramide), and homeopathic agents (cinchona, licorice extract- glycyrrhizin). 3. Hypertension with confirmed systolic blood pressure >140 mmHg or confirmed diastolic blood pressure > 90 mmHg, measured after 10 to 15 minutes of rest 4. Morbid obesity (BMI >/= 35 kg/m^2) 5. Current diagnosis of pulmonary disease 6. History or current diagnosis of diabetes 7. Autoimmune disorders, such as lupus, Wegener's, rheumatoid arthritis 8. History of malignancy except low-grade skin cancer, (i.e., basal cell carcinoma thought to be cured) 9. Known diagnosis of prolonged QT interval, congenital long QT syndrome, bradyarrhythmias or uncompensated heart failure 10. History of alcohol abuse 11. History of seizure disorder 12. History of renal disease 13. Chronic renal, hepatic, or pulmonary disease or other condition that could interfere with the absorption of the study drug or predispose to adverse GI events (e.g., surgical resection of significant proportions of the stomach or bowel, gastric bypass, gastric banding, irritable bowel syndrome, inflammatory bowel disease) 14. Positive serology results for HIV, hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies 15. Subjects who have taken any prescription drugs in the previous 14 days or within five half-lives before dosing 16. Ingestion of OTC medications or herbal supplements within seven days of dosing 17. Positive urine drug screen for marijuana, cocaine, amphetamines, opiates, phencyclidine, barbiturates, or benzodiazepines 18. History of allergic reaction or intolerance to cephalosporins 19. History of allergic reaction to penicillin (all stages) 20. History of allergic reaction to azithromycin, erythromycin, or any macrolide or ketolide antibiotic 21. History of jaundice or hepatic dysfunction associated with prior use of azithromycin 22. Males with a QTcF > 430ms or Females with a QTcF >450ms (Fridericia's correction) on screening 23. Positive pregnancy test; pregnant or nursing women 24. Screening laboratory tests > Grade 1 as defined by Appendix B 25. Any specific condition that, in the judgment of the Investigator, precludes participation because it could affect subject safety.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Azithromycin | Drug | Cefixime/Azithromycin |
| Cefixime | Drug | Cefixime/Azithromycin |
Primary outcome
AUC from 0 to infinity [AUC0-infinity]
Time frame: Day 1,2,3,10,11,12 and at early termination
Averaged composite plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Time frame: Day 1,2,3,10,11,12 and at early termination
Elimination half-life (t1/2)
Time frame: Day 1,2,3,10,11,12 and at early termination
Elimination rate (lambda z)
Time frame: Day 1,2,3,10,11,12 and at early termination
Individual plasma cefixime levels will be used to generate PK curves of cefixime levels versus time
Time frame: Day 1,2,3,10,11,12 and at early termination
Peak cefixime level (Cmax)
Time frame: Day 1,2,3,10,11,12 and at early termination
Safety blood test results
Time frame: Day: -28,-1, 2, 3, 9, 11, 12, 17 and at early termination
Safety urinanalysis results
Time frame: Day: -28, -1, 2, 3, 9, 11, 12, 17 and at early termination
Subject reported AEs
Time frame: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Subject reported serious adverse events (SAEs)
Time frame: Day: 1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Targeted clinical evaluations
Time frame: Day: -1,1, 2, 3, 9, 10, 11, 12, 17 and at early termination
Time that cefixime levels exceed four times the MIC of 0.5 mcg/mL (i.e., a plasma level of 2.0 mcg/mL)
Time frame: Day 1,2,3,10,11,12 and at early termination
Time to peak drug level (Tmax)
Time frame: Day 1,2,3,10,11,12 and at early termination
Total area under the curve (AUC from 0 hours to the time of next dosing [AUC0-t])
Time frame: Day 1,2,3,10,11,12 and at early termination
Total plasma concentrations of cefixime
Time frame: Day 1,2,3,10,11,12 and at early termination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azithromycin and Cefixime in people with Gonorrhoea, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC from 0 to infinity [AUC0-infinity] (time frame: Day 1,2,3,10,11,12 and at early termination). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2017.