Condition category
Nutritional, Metabolic, Endocrine
Date applied
03/06/2008
Date assigned
10/06/2008
Last edited
02/02/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nahashon Thuo

ORCID ID

Contact details

P.O. Box 230
Kilifi
80108
Kenya

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

077092

Study information

Scientific title

Population pharmacokinetics of oral ciprofloxacin in children with severe malnutrition

Acronym

Study hypothesis

Mortality 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

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).

Study design

Single centre, single arm, non-randomised, population PK trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Severe acute malnutrition

Intervention

Current 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 type

Drug

Phase

Not Applicable

Drug names

Ciprofloxacin

Primary outcome measures

Determine 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 measures

Define 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 trial start date

09/06/2008

Overall trial end date

26/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

36 (52 as of 02/02/2009)

Participant exclusion criteria

1. 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

Recruitment start date

09/06/2008

Recruitment end date

26/03/2009

Locations

Countries of recruitment

Kenya

Trial participating centre

P.O. Box 230
Kilifi
80108
Kenya

Sponsor information

Organisation

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

Sponsor details

P.O. Box 230
KIlifi
80108
Kenya

Sponsor type

Research organisation

Website

http://www.kemri-wellcome.org

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes