Examining whether any interactions occur between the antibiotic Ciprofloxacin and the antimalarial treatment Chloroquine/Proguanil
| ISRCTN | ISRCTN20647977 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN20647977 |
| EudraCT/CTIS number | 2005-004905-27 |
| Secondary identifying numbers | CBD VP 132/05 |
- Submission date
- 17/01/2019
- Registration date
- 05/04/2019
- Last edited
- 12/04/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Background and study aims
The aim of the study was to check whether two medicines commonly used together by military personnel affect how the medicines are absorbed and eliminated by the body and whether both medicines taken at once are well tolerated.
Who can participate?
Healthy male subjects aged between 18 and 50 years.
What does the study involve?
The study involves taking tablets (antibiotics and/or antimalarial tablets) over a three week period. People entering the study were assigned to either group 1 or group 2. People in group 1 took antibiotic tablets plus antimalarial tablets, whereas people in group 2 took antimalarial tablets.
What are the possible benefits and risks of participating?
There were no direct individual benefits for the subjects participating. All medicinal products can on occasions cause unwanted effects, but no participant experienced any significant adverse effects attributable to the medicines studied.
Where is the study run from?
The study was run from- Dstl, Porton Down, Salisbury.
When is the study starting and how long is it expected to run for?
November 2005 to June 2010.
Who is funding the study?
This study was funded by the UK Ministry of Defence.
Contact information
Dr Medical Officer
Scientific
Scientific
Defence Science and Technology Laboratory, Porton Down
Salisbury
SP4 0JQ
United Kingdom
Study information
| Study design | Randomised, parallel-group, open label study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | Pharmacokinetic Interactions between Ciprofloxacin and Chloroquine/Proguanil Prophylaxis in healthy young males: a randomised, parallel-group, open label study |
| Study objectives | Trial rationale was to to determine whether any pharmacokinetic interactions occur during the concomitant oral administration of Chloroquine/Proguanil with Ciprofloxacin in healthy subjects. |
| Ethics approval(s) | Oxfordshire Research Ethics Committee A, 01/02/2008, ref. 07/H0604/155. |
| Health condition(s) or problem(s) studied | Pharmacokinetics |
| Intervention | Ciprofloxacin and Chloroquine/Proguanil Route of administration - oral Doses- 500 mg ciprofloxacin, 200 mg proguanil, 500 mg chloroquine phosphate Brief methodology: Ciprofloxacin Generic drug name: ciprofloxacin Dosage given: 500mg Method and frequency of administration: oral route. Ciprofloxacin was administered as 2 x 250 mg tablets orally on Day 1 and again on Day 22 to subjects in Group 1 only. Total duration of treatment: 2 single doses separated by 21 days Chloroquine Generic drug name: chloroquine Dosage given: 500mg Chloroquine was administered as 2 x 250 mg tablets orally once a week, starting on Day 8, for 15 days (i.e. on 3 occasions) to subjects in both Groups 1 and 2. On the third occasion (Day 22) it was combined with a ciprofloxacin dose (500 mg) for subjects in Group 1 only. Total duration of treatment: 2 weeks Proguanil Generic drug name: proguanil Dosage given: 200mg Method and frequency of administration: Proguanil was administered as 2 x 100 mg tablets orally once daily for 15 days, starting from Day 8, to subjects in both Groups 1 and 2. It was combined with a chloroquine dose on Day 8, Day 15 and Day 22 and combined with a ciprofloxacin dose (500 mg) on Day 22 for subjects in Group 1 only. Total duration of treatment: 2 weeks |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ciprofloxacin and Chloroquine/Proguanil |
| Primary outcome measure | 1. Any interaction occurring with concomitant oral administration of chloroquine/proguanil with ciprofloxacin was measured using pharmacokinetic (PK) parameters at day 1, day 2, day 22, and days 23to 25. These parameters were assessed during administration of: 1.1. Chloroquine and Proguanil together 1.2. Chloroquine and Proguanil together in combination with Ciprofloxacin 1.3. Ciprofloxacin alone |
| Secondary outcome measures | 1. Safety of concomitant oral administration of Chloroquine/Proguanil with Ciprofloxacin was measured using the following measures pre and post-study: 1.1. Medical History and Physical Examinations 1.2. Vital Signs (supine blood pressure and pulse rate) 1.3. Laboratory Safety Screening: haematology, biochemistry and urinalysis were carried out pre and post study. 2. Tolerability of concomitant oral administration of Chloroquine/Proguanil with Ciprofloxacin was measured using Adverse Event Recording: performed throughout the study. |
| Overall study start date | 25/11/2005 |
| Completion date | 14/06/2010 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Male |
| Target number of participants | Planned recruitment of 16 healthy male subjects |
| Total final enrolment | 16 |
| Key inclusion criteria | 1. Ability and willingness to give written informed consent prior to study participation 2. Healthy male subjects aged between 18 and 50 years (inclusive) 3. Body Mass Index (BMI) within the range of 21 and 30 kg/m2 4. Vital signs within the following ranges: 4.1. Pulse rate 40-90 bpm 4.2. Systolic blood pressure 90-140 mmHg 4.3. Diastolic blood pressure 50-90 mmHg 5. Ability to communicate well with the Investigator and to comply with the requirements of the study. |
| Key exclusion criteria | 1. Presence of any clinically significant medical condition as determined by the Investigator or Medical Advisor 2. Any clinically significant haematological or biochemical abnormality as determined by the Investigator or Medical Advisor 3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders) 4. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia 5. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products 6. Positive test for hepatitis B surface antigen or Hepatitis C antibody 7. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 mL beer, 20 mL spirits/liqueur or one glass (100 mL) of wine 8. Participation in another clinical study within the three months prior to screening 9. Use of any prescription medication within the 14 days prior to screening 10. Use of any non-prescription medication within the last 7 days (apart from paracetamol), which may, in the opinion of the Investigator or Medical Advisor, impact the safety aspects and/or objectives of the study 11. Donation of blood or blood products within the 3 months prior to screening, or the intention to donate blood or blood products within 3 months after completion of the study. |
| Date of first enrolment | 01/02/2008 |
| Date of final enrolment | 10/10/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Dstl, Porton Down
Salisbury
SP40JQ
United Kingdom
SP40JQ
United Kingdom
Sponsor information
Defence Science and Technology Laboratory (Dstl)
Government
Government
Porton Down
Salisbury
SP4 0JQ
United Kingdom
"ROR" |
https://ror.org/04jswqb94 |
|---|
Funders
Funder type
Government
Ministry of Defence
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- MOD
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 31/12/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Our intention is to submit the results of this study for publication in an academic journal as soon as we have sufficient staff resources to prepare the manuscript. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to lack of subject consent being obtained at the time of the study. |
Editorial Notes
12/04/2019: Internal review.
