A study of the concentration of ciprofloxacin in the body over time when given by mouth

ISRCTN ISRCTN31079753
DOI https://doi.org/10.1186/ISRCTN31079753
Secondary identifying numbers 077092
Submission date
03/06/2008
Registration date
10/06/2008
Last edited
02/02/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Nahashon Thuo
Scientific

P.O. Box 230
Kilifi
80108
Kenya

Study information

Study designSingle centre, single arm, non-randomised, population PK trial
Primary study designInterventional
Secondary study designNon randomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePopulation pharmacokinetics of oral ciprofloxacin in children with severe malnutrition
Study objectivesMortality among children with severe malnutrition has remained high especially for those with proven bacteraemia. The currently recommended antibiotics offer sub-optimal cover for gram negative infections. Ciprofloxacin has good gram negative cover and can be given as an oral formulation owing to its good oral bioavailability over norfloxacin and good tissue penetration, which give concentrations that are at least equivalent to the minimum inhibitory concentration designated as the breakpoint of bacterial susceptibility in vitro.

It has been used widely in children with cystic fibrosis and immunocompromised children without any significant toxicity. The previous cost of the newer generations of oral quinolones was prohibitive and so pharmacokinetics (PK) in such populations could not be justified on the basis of limited application. The availability of cheaper formulations of the oral quinolones coupled with poor prognosis of children with severe malnutrition and gram negative infection on current standard treatment support the value of this study. No studies have been done on the PK of ciprofloxacin in children with severe malnutrition. This will provide a model to predict PK of ciprofloxacin in this group. Again this data will assist with the future national and international treatment guidelines for children with severe malnutrition.

Please note as of 02/02/2009 this record was amended to include a change to the interventions and a change to the number of participants. Ethics approval has been received for these amendments. Please also note that at this time a public title was added to this record and the initial public title moved to the scientific title field.
Ethics approval(s)Ethics approval received from the Kenya Medical Research Institute (KEMRI) Ethical Review Committee (ERC) on the 27th March 2008 (Scientific Steering Committee [SSC] ref: 1331).
Health condition(s) or problem(s) studiedSevere acute malnutrition
InterventionCurrent information as of 02/02/2009:
In 36 children, ciprofloxacin will be given 2 hours after the child has received his/her first feed and medication. 16 children will have ciprofloxacin administered together with the first feed in order to investigate whether milk based formula diets (F75/F100) alters the pharmacokinetics of ciprofloxacin in children with severe malnutrition. Patients will be given ciprofloxacin orally, 10 mg/kg, twice daily for two days.

The children will be reviewed daily until they are disharged and then on day 28.

Initial information at time of registration:
Children will be divided into three groups based on severity. From each group there will be three subgroups for sampling times for four samples. Patients will be given ciprofloxacin orally, 10 mg/kg, twice daily for two days.

The children will be reviewed daily until they are disharged and then on day 28.
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Ciprofloxacin
Primary outcome measureDetermine the peak plasma concentrations of ciprofloxacin.

Measured:
Group 1: at 2, 4, 8, 24 hours
Group 2: at 3, 5, 9, 12 hours
Group 3: at 1, 3, 6, 10 hours
Secondary outcome measuresDefine which co-variates influence the pharmacokinetics of ciprofloxacin in this group of patients:
1. Age, assessed on admission (0 hour)
2. Sex, assessed on admission (0 hour)
3. Anthropometric indices, assessed on admission (0 hour)
4. Haemodynamic status, measured at 0 hour and 48 hour
5. Concomitant medications, reviewed every 4 hours
Overall study start date09/06/2008
Completion date26/03/2009

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit6 Months
SexBoth
Target number of participants36 (52 as of 02/02/2009)
Key inclusion criteria1. Aged over 6 months, either sex
2. Consent given
3. Severe malnutrition as defined by weight-for-height Z score (WHZ) less than -3 or bilateral oedema (of kwashiorkor) or mid-upper arm circumference (MUAC) less than 11.0 cm (if greater than 65 cm in length)
4. Able to take and retain oral treatment
Key exclusion criteria1. Admission plasma creatinine greater than 300 and evidence of intrinsic renal disease (hypertension or hyperkalaemia)
2. Coexisting bone or joint disease
3. Concurrent use of antacids, ketoconazole, theophylline, corticosteroids
4. Enrolment in another interventional study
Date of first enrolment09/06/2008
Date of final enrolment26/03/2009

Locations

Countries of recruitment

  • Kenya

Study participating centre

P.O. Box 230
Kilifi
80108
Kenya

Sponsor information

Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya)
Research organisation

P.O. Box 230
KIlifi
80108
Kenya

Website http://www.kemri-wellcome.org
ROR logo "ROR" https://ror.org/04r1cxt79

Funders

Funder type

Research organisation

Kenya Medical Research Institute (KEMRI) Wellcome Trust Research Programme (Kenya) (ref: 077092)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan