|
View: |
Part 1: Document Description
|
|
Citation |
|
|---|---|
|
Title: |
Replication Data for: Dosing of ceftriaxone and metronidazole for children with severe acute malnutrition. |
|
Identification Number: |
doi:10.7910/DVN/YBRNXC |
|
Distributor: |
Harvard Dataverse |
|
Date of Distribution: |
2020-02-20 |
|
Version: |
1 |
|
Bibliographic Citation: |
Standing, Joseph F.; Ongas, Martin O.; Ogwang, Caroline; Kagwanja, Nancy; Murunga, Sheila; Mwaringa,Shalton; Ali, Rehema; Mturi, Neema; Timbwa, Moline; Manyasi, Christine; Mwalekwa, Laura; Bandika, Victor L.; Ogutu, Bernhards; Waichungo, Joseph; Kipper, Karin; Berkley, James A.; FLACSAM‐PK Study Group, 2020, "Replication Data for: Dosing of ceftriaxone and metronidazole for children with severe acute malnutrition.", https://doi.org/10.7910/DVN/YBRNXC, Harvard Dataverse, V1, UNF:6:xbfwNn54224wmyZxmCxuvQ== [fileUNF] |
|
Citation |
|
|
Title: |
Replication Data for: Dosing of ceftriaxone and metronidazole for children with severe acute malnutrition. |
|
Identification Number: |
doi:10.7910/DVN/YBRNXC |
|
Authoring Entity: |
Standing, Joseph F. (Great Ormond Street Institute of Child Health, University College London, London, UK; Paediatric Infectious Diseases Research Group, Institute for Infection and Immunity, St. George's, University of London, London, UK) |
|
Ongas, Martin O. (Center for Research in Therapeutic Sciences, Strathmore University, Nairobi, Kenya; KEMRI‐Centre for Clinical Research, Nairobi, Kenya) |
|
|
Ogwang, Caroline (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Kagwanja, Nancy (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Murunga, Sheila (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Mwaringa,Shalton (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Ali, Rehema (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Mturi, Neema (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Timbwa, Moline (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya; Mbagathi County Hospital, Nairobi, Kenya) |
|
|
Manyasi, Christine (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya; Mbagathi County Hospital, Nairobi, Kenya) |
|
|
Mwalekwa, Laura (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya; Coast General Hospital, Mombasa, Kenya) |
|
|
Bandika, Victor L. (Coast General Hospital, Mombasa, Kenya) |
|
|
Ogutu, Bernhards (Center for Research in Therapeutic Sciences, Strathmore University, Nairobi, Kenya; KEMRI‐Centre for Clinical Research, Nairobi, Kenya) |
|
|
Waichungo, Joseph (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya) |
|
|
Kipper, Karin (Analytical Services International, St George's University of London, London, UK; Institute of Chemistry, University of Tartu, Tartu, Estonia) |
|
|
Berkley, James A. (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya; The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK) |
|
|
FLACSAM‐PK Study Group (KEMRI‐Wellcome Trust Research Programme, Kilifi, Kenya; The Childhood Acute Illness & Nutrition (CHAIN) Network, Nairobi, Kenya; Centre for Tropical Medicine & Global Health, Nuffield Department of Medicine, University of Oxford, Oxford, UK) |
|
|
Distributor: |
Harvard Dataverse |
|
Access Authority: |
Berkley, James A. |
|
Depositor: |
Berkley, James A. |
|
Date of Deposit: |
2020-02-17 |
|
Holdings Information: |
https://doi.org/10.7910/DVN/YBRNXC |
|
Study Scope |
|
|
Keywords: |
Medicine, Health and Life Sciences |
|
Abstract: |
<p>This study forms the initial stage of the First Line Antimicrobials in Complicated Severe Acute Malnutrition (FLACSAM) trial (<a href="https://clinicaltrials.gov/ct2/show/NCT03174236">http://clinicaltrials.gov NCT03174236</a>), which will compare ceftriaxone (±metronidazole) with standard‐of‐care antimicrobials (±metronidazole) in a 2 × 2 factorial design for outcomes including mortality and nutritional recovery. Infants and young children with severe acute malnutrition (SAM) are treated with empiric broad‐spectrum antimicrobials. Parenteral ceftriaxone is currently a second‐line agent for invasive infection. Oral metronidazole principally targets small intestinal bacterial overgrowth. Children with SAM may have altered drug absorption, distribution, metabolism, and elimination. Population pharmacokinetics of ceftriaxone and metronidazole were studied, with the aim of recommending optimal dosing. Eighty‐one patients with SAM (aged 2–45 months) provided 234 postdose pharmacokinetic samples for total ceftriaxone, metronidazole, and hydroxymetronidazole. Ceftriaxone protein binding was also measured in 190 of these samples. A three‐compartment model adequately described free ceftriaxone, with a Michaelis–Menten model for concentration and albumin‐dependent protein binding. A one‐compartment model was used for both metronidazole and hydroxymetronidazole, with only 1% of hydroxymetronidazole predicted to be formed during first‐pass. Simulations showed 80 mg/kg once daily of ceftriaxone and 12.5 mg/kg twice daily of metronidazole were sufficient to reach therapeutic targets.</p> |
|
Kind of Data: |
Clinical Trial |
|
Notes: |
Access to the dataset is restricted. Accompanying documentation is available under open access. For more detailed information beyond the metadata and documentation provided, there is a process of managed access requiring submission of a request form for consideration by our Data Governance Committee [dgc@kemri-wellcome.org).<strong> <a href="https://kemri-wellcome.org/wp-content/uploads/2016/02/Data-Sharing-guidelines-External-requests.docx">Click to download Data Request Form</a></strong> |
|
Methodology and Processing |
|
|
Sources Statement |
|
|
Data Access |
|
|
Citation Requirement: |
Publications based on this data collection should acknowledge this source by means of bibliographic citation. |
|
Notes: |
<p>This data is licensed under the <a href="https://creativecommons.org/licenses/by/4.0/legalcode">Creative Commons Attribution 4.0 International</a> <a href="https://creativecommons.org/licenses/by/4.0/legalcode"><img src="https://i.creativecommons.org/l/by/3.0/88x31.png"> </a> </p> |
|
Access to the dataset is restricted. Accompanying documentation is available under open access. For more detailed information beyond the metadata and documentation provided, there is a process of managed access requiring submission of a request form for consideration by our Data Governance Committee [dgc@kemri-wellcome.org).<strong> <a href="https://kemri-wellcome.org/wp-content/uploads/2016/02/Data-Sharing-guidelines-External-requests.docx">Click to download Data Request Form</a></strong> |
|
|
Other Study Description Materials |
|
|
Related Publications |
|
|
Citation |
|
|
Title: |
Standing, J.F., Ongas, M.O., Ogwang, C., Kagwanja, N., Murunga, S., Mwaringa, S., Ali, R., Mturi, N., Timbwa, M., Manyasi, C. and Mwalekwa, L., 2018. Dosing of ceftriaxone and metronidazole for children with severe acute malnutrition. Clinical Pharmacology & Therapeutics, 104(6), pp.1165-1174. |
|
Identification Number: |
10.1002%2Fcpt.1078 |
|
Bibliographic Citation: |
Standing, J.F., Ongas, M.O., Ogwang, C., Kagwanja, N., Murunga, S., Mwaringa, S., Ali, R., Mturi, N., Timbwa, M., Manyasi, C. and Mwalekwa, L., 2018. Dosing of ceftriaxone and metronidazole for children with severe acute malnutrition. Clinical Pharmacology & Therapeutics, 104(6), pp.1165-1174. |
|
File Description--f3724522 |
|
|
File: FLACSAM_pk_cef_170102.tab |
|
|
|
|
Notes: |
UNF:6:WjzOThwkZFkzYo02lwfj1w== |
|
Contains Ceftriaxone related data |
|
|
File Description--f3724523 |
|
|
File: FLACSAM_pk_met_170104.tab |
|
|
|
|
Notes: |
UNF:6:3SfuTv46VIWiiYP+GaXRgQ== |
|
Contains Metronidazole related data |
|
|
Label: |
FLACSAM_PK_data_manip_V03_final.pdf |
|
Text: |
Output generated using 'FLACSAM_PK_data_manip_V03_final.Rmd' |
|
Notes: |
application/pdf |
|
Label: |
FLACSAM_PK_data_manip_V03_final.Rmd |
|
Text: |
R script |
|
Notes: |
application/octet-stream |