Respiratory Tract Infections Clinical Trial
— COORDINATEOfficial title:
Using the CRP Test in Children Under 12 Years With Respiratory Symptoms in Kyrgyz Republic
NCT number | NCT05195866 |
Other study ID # | CRPKG |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 1, 2022 |
Est. completion date | April 6, 2023 |
Verified date | April 2023 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Rationale: Overuse of antibiotics globally is leading to increasing rates of antibiotic resistance and may lead to a 'post-antibiotic' era. Case fatality rates for pneumonia in children remain high in Central Asia and there is a lack of knowledge of which viruses and bacteria cause the disease. Antibiotic resistance patterns of common bacteria remain largely unknown in Central Asia which makes it challenging for clinicians to choose the right antibiotic to treat children with suspected bacterial pneumonia and sometimes healthcare workers overuse an antibacterial therapy even when the child does not need it. Randomised trials of using CRP point of care test (POCT) to guide antibiotic prescription for respiratory tract infections has been successful in lowering unnecessary antibiotic prescriptions in adults in high income countries but left a small concern for safety in the form of possibly slightly increased risk of hospitalisation in the CRP group. Objective: This study seeks to gain evidence on whether use of C-reactive protein point-of-care test can safely decrease prescription of antibiotics for children under 12 with acute respiratory symptoms in primary level healthcare centres in Kyrgyzstan. Study design: Multicentre, open-label, individual randomised controlled clinical trial with 14 days blinded follow-up in rural Chui and Naryn regions of Kyrgyz Republic. Healthcare workers from ten selected healthcare centres will be trained in the CRP POCT and in interpreting the results in the field. Study population: Children aged from 6 month to 12 years attending the primary level healthcare centres during normal business hours with acute respiratory symptoms. Main study parameters: The proportion of patients in the two groups prescribed an antibiotic within 14 days of index consultation; length of disease, antibiotics given at index consultation, admissions and vital status. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risks, inconvenience and burden associated with participating in this observational study are low. As part of the inclusion children in the CRP cluster group will have a finger-prick test performed. This may be unpleasant and course transient discomfort but poses no risks to the child. Follow-up will be three short phone calls day 3, 7 and 14 after inclusion. Risks includes possible undertreatment of serious disease, however previous studies have not found safety issues with CRP testing in children. There is no direct benefit to participants, but side effects and non-necessary medications are likely minimised.
Status | Completed |
Enrollment | 1204 |
Est. completion date | April 6, 2023 |
Est. primary completion date | April 6, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 12 Years |
Eligibility | Inclusion Criteria: - Between 6 month and 12 years of age; - Parents/caregivers of a child are able and willing to comply with all study requirements; - Parents/caregivers of a child is able and willing to give Informed Consent; - Having at least one of the following focal symptoms lasting for less than 2 weeks (cough; fast/difficult breathing; dore throat; shortness of breath; wheezing) Exclusion Criteria: - Severely ill and in need of urgent referral where measurement of CRP POCT would delay the process; - Terminally ill patients; - Patients with ear ache only; - Patients with known immunosuppression or severe chronic disease (HIV, liver disease, history of neoplastic disease, long term systemic steroid use or similar conditions as assessed by the health worker or AI); - Parents/caregivers who are not able to participate in follow-up procedures (lack of telephone etc); - Haven taken antibiotics within 24 hours before the index consultation |
Country | Name | City | State |
---|---|---|---|
Kyrgyzstan | At-Bashy FMC | Naryn | Naryn Region |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark | Copenhagen School of Global Health, Kyrgyz Thoracic Society, National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov, National Center of Maternity and Childhood Care, The Research Unit for General Practice, Unit of Global Health, The Juliane Marie Center, Rigshospitalet |
Kyrgyzstan,
Aabenhus R, Jensen JU, Jorgensen KJ, Hrobjartsson A, Bjerrum L. Biomarkers as point-of-care tests to guide prescription of antibiotics in patients with acute respiratory infections in primary care. Cochrane Database Syst Rev. 2014 Nov 6;(11):CD010130. doi: 10.1002/14651858.CD010130.pub2. — View Citation
Althaus T, Greer RC, Swe MMM, Cohen J, Tun NN, Heaton J, Nedsuwan S, Intralawan D, Sumpradit N, Dittrich S, Doran Z, Waithira N, Thu HM, Win H, Thaipadungpanit J, Srilohasin P, Mukaka M, Smit PW, Charoenboon EN, Haenssgen MJ, Wangrangsimakul T, Blacksell S, Limmathurotsakul D, Day N, Smithuis F, Lubell Y. Effect of point-of-care C-reactive protein testing on antibiotic prescription in febrile patients attending primary care in Thailand and Myanmar: an open-label, randomised, controlled trial. Lancet Glob Health. 2019 Jan;7(1):e119-e131. doi: 10.1016/S2214-109X(18)30444-3. — View Citation
Do NT, Ta NT, Tran NT, Than HM, Vu BT, Hoang LB, van Doorn HR, Vu DT, Cals JW, Chandna A, Lubell Y, Nadjm B, Thwaites G, Wolbers M, Nguyen KV, Wertheim HF. Point-of-care C-reactive protein testing to reduce inappropriate use of antibiotics for non-severe acute respiratory infections in Vietnamese primary health care: a randomised controlled trial. Lancet Glob Health. 2016 Sep;4(9):e633-41. doi: 10.1016/S2214-109X(16)30142-5. Epub 2016 Aug 3. Erratum In: Lancet Glob Health. 2017 Jan;5(1):e39. — View Citation
Haenssgen MJ, Charoenboon N, Do NTT, Althaus T, Khine Zaw Y, Wertheim HFL, Lubell Y. How context can impact clinical trials: a multi-country qualitative case study comparison of diagnostic biomarker test interventions. Trials. 2019 Feb 8;20(1):111. doi: 10.1186/s13063-019-3215-9. — View Citation
Havers FP, Hicks LA, Chung JR, Gaglani M, Murthy K, Zimmerman RK, Jackson LA, Petrie JG, McLean HQ, Nowalk MP, Jackson ML, Monto AS, Belongia EA, Flannery B, Fry AM. Outpatient Antibiotic Prescribing for Acute Respiratory Infections During Influenza Seasons. JAMA Netw Open. 2018 Jun 1;1(2):e180243. doi: 10.1001/jamanetworkopen.2018.0243. — View Citation
Hazir T, Nisar YB, Abbasi S, Ashraf YP, Khurshid J, Tariq P, Asghar R, Murtaza A, Masood T, Maqbool S. Comparison of oral amoxicillin with placebo for the treatment of world health organization-defined nonsevere pneumonia in children aged 2-59 months: a multicenter, double-blind, randomized, placebo-controlled trial in pakistan. Clin Infect Dis. 2011 Feb 1;52(3):293-300. doi: 10.1093/cid/ciq142. Epub 2010 Dec 28. — View Citation
Hug L, Sharrow D, You D. Levels & Trends in Child Mortality. New York, 2017 http://www.childmortality.org/files_v21/download/IGME report 2017 child mortality final.pdf.
Keitel K, Samaka J, Masimba J, Temba H, Said Z, Kagoro F, Mlaganile T, Sangu W, Genton B, D'Acremont V. Safety and Efficacy of C-reactive Protein-guided Antibiotic Use to Treat Acute Respiratory Infections in Tanzanian Children: A Planned Subgroup Analysis of a Randomized Controlled Noninferiority Trial Evaluating a Novel Electronic Clinical Decision Algorithm (ePOCT). Clin Infect Dis. 2019 Nov 13;69(11):1926-1934. doi: 10.1093/cid/ciz080. — View Citation
Kjaergaard J, Anastasaki M, Stubbe Ostergaard M, Isaeva E, Akylbekov A, Nguyen NQ, Reventlow S, Lionis C, Sooronbaev T, Pham LA, Nantanda R, Stout JW, Poulsen A; FRESH AIR Collaborators. Diagnosis and treatment of acute respiratory illness in children under five in primary care in low-, middle-, and high-income countries: A descriptive FRESH AIR study. PLoS One. 2019 Nov 6;14(11):e0221389. doi: 10.1371/journal.pone.0221389. eCollection 2019. Erratum In: PLoS One. 2020 Feb 20;15(2):e0229680. — View Citation
Lai CK, Beasley R, Crane J, Foliaki S, Shah J, Weiland S; International Study of Asthma and Allergies in Childhood Phase Three Study Group. Global variation in the prevalence and severity of asthma symptoms: phase three of the International Study of Asthma and Allergies in Childhood (ISAAC). Thorax. 2009 Jun;64(6):476-83. doi: 10.1136/thx.2008.106609. Epub 2009 Feb 22. — View Citation
Liu L, Oza S, Hogan D, Perin J, Rudan I, Lawn JE, Cousens S, Mathers C, Black RE. Global, regional, and national causes of child mortality in 2000-13, with projections to inform post-2015 priorities: an updated systematic analysis. Lancet. 2015 Jan 31;385(9966):430-40. doi: 10.1016/S0140-6736(14)61698-6. Epub 2014 Sep 30. Erratum In: Lancet. 2015 Jan 31;385(9966):420. Lancet. 2016 Jun 18;387(10037):2506. — View Citation
Nantanda R, Tumwine JK, Ndeezi G, Ostergaard MS. Asthma and pneumonia among children less than five years with acute respiratory symptoms in Mulago Hospital, Uganda: evidence of under-diagnosis of asthma. PLoS One. 2013 Nov 29;8(11):e81562. doi: 10.1371/journal.pone.0081562. eCollection 2013. — View Citation
O'Neill J. Tackling Drug-Resistant Infections Globally: Final Report and Recommendations. 2016 https://amr-review.org/sites/default/files/160525_Final paper_with cover.pdf.
Risk R, Naismith H, Burnett A, Moore SE, Cham M, Unger S. Rational prescribing in paediatrics in a resource-limited setting. Arch Dis Child. 2013 Jul;98(7):503-9. doi: 10.1136/archdischild-2012-302987. Epub 2013 May 9. — View Citation
Shao AF, Rambaud-Althaus C, Samaka J, Faustine AF, Perri-Moore S, Swai N, Kahama-Maro J, Mitchell M, Genton B, D'Acremont V. New Algorithm for Managing Childhood Illness Using Mobile Technology (ALMANACH): A Controlled Non-Inferiority Study on Clinical Outcome and Antibiotic Use in Tanzania. PLoS One. 2015 Jul 10;10(7):e0132316. doi: 10.1371/journal.pone.0132316. eCollection 2015. — View Citation
WHO. ANTIMICROBIAL RESISTANCE Global Report on Surveillance. Geneva, 2014 http://apps.who.int/iris/bitstream/10665/112642/1/9789241564748_eng.pdf?ua=1.
WHO. Integrated Management of Childhood Illness Chart Booklet. 2014.
Zar HJ, Ferkol TW. The global burden of respiratory disease-impact on child health. Pediatr Pulmonol. 2014 May;49(5):430-4. doi: 10.1002/ppul.23030. Epub 2014 Mar 9. — View Citation
* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of children receiving antibiotics | The primary study outcome is the proportion of included children in each study arm that are prescribed an antibiotic within 14 days from the index consultation (superiority analysis). | Up to 1 year | |
Primary | Patient safety | The second primary study outcome is patient safety measured as the number of days until recovery (non-inferiority analysis). | Up to 1 year | |
Secondary | Antibiotics prescribed at the index consultation | Number of children who were prescribed antibiotics at the index consultation | Up to 1 year | |
Secondary | Antiviral treatment at follow up | Number of children who were prescribed antiviral treatment at the follow up | Up to 1 year | |
Secondary | Reconsultation within 14 days from index consultation | Number of reconsultations within 14 days from index consultation | Up to 1 year | |
Secondary | Hospital referral at index consultation | Number of hospitalisations at index consultation | Up to 1 year | |
Secondary | Hospital admission at follow up | Number of hospital admissions at follow up | Up to 1 year | |
Secondary | Mortality | Number of children who died from the index consultation till the follow-up | Up to 1 year |
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