@article{Salami2020-lo,

title = {Impact of a package of diagnostic tools, clinical algorithm, and  training and communication on outpatient acute fever case  management in low- and middle-income countries: protocol for a  randomized controlled trial},

author = {Olawale Salami and Philip Horgan and Catrin E Moore and Abhishek Giri and Asadu Sserwanga and Ashish Pathak and Buddha Basnyat and Francois Kiemde and Frank Smithuis and Freddy Kitutu and Gajanan Phutke and Halidou Tinto and Heidi Hopkins and James Kapisi and Myo Maung Maung Swe and Neelam Taneja and Rita Baiden and Shanta Dutta and Adelaide Compaore and David Kaawa-Mafigiri and Rashida Hussein and Summita Udas Shakya and Vida Kukula and Stefano Ongarello and Anjana Tomar and Sarabjit S Chadha and Kamini Walia and Cassandra Kelly-Cirino and Piero Olliaro},

doi = {10.1186/s13063-020-04897-9},

issn = {1745-6215},

year  = {2020},

date = {2020-11-25},

urldate = {2020-11-01},

journal = {Trials},

volume = {21},

number = {1},

pages = {974},

publisher = {Springer Science and Business Media LLC},

abstract = {BACKGROUND: The management of acute febrile illnesses places a 

 heavy burden on clinical services in many low- and middle-income 

 countries (LMICs). Bacterial and viral aetiologies of acute 

 fevers are often clinically indistinguishable and, in the 

 absence of diagnostic tests, the 'just-in-case' use of 

 antibiotics by many health workers has become common practice, 

 which has an impact on drug-resistant infections. Our study aims 

 to answer the following question: in patients with 

 undifferentiated febrile illness presenting to outpatient 

 clinics/peripheral health centres in LMICs, can we demonstrate 

 an improvement in clinical outcomes and reduce unnecessary 

 antibiotic prescription over current practice by using a 

 combination of simple, accurate diagnostic tests, clinical 

 algorithms, and training and communication (intervention 

 package)? METHODS: We designed a randomized, controlled clinical 

 trial to evaluate the impact of our intervention package on 

 clinical outcomes and antibiotic prescription rates in acute 

 febrile illnesses. Available, point-of-care, pathogen-specific 

 and non-pathogen specific (host markers), rapid diagnostic tests 

 (RDTs) included in the intervention package were selected based 

 on pre-defined criteria. Nine clinical study sites in six 

 countries (Burkina Faso, Ghana, India, Myanmar, Nepal and 

 Uganda), which represent heterogeneous outpatient care settings, 

 were selected. We considered the expected seasonal variations in 

 the incidence of acute febrile illnesses across all the sites by 

 ensuring a recruitment period of 12 months. A master protocol 

 was developed and adapted for country-specific ethical 

 submissions. Diagnostic algorithms and choice of RDTs 

 acknowledged current data on aetiologies of acute febrile 

 illnesses in each country. We included a qualitative evaluation 

 of drivers and/or deterrents of uptake of new diagnostics and 

 antibiotic use for acute febrile illnesses. Sample size 

 estimations were based on historical site data of antibiotic 

 prescription practices for malarial and non-malarial acute 

 fevers. Overall, 9 semi-independent studies will enrol a minimum 

 of 21,876 patients and an aggregate data meta-analysis will be 

 conducted on completion. DISCUSSION: This study is expected to 

 generate vital evidence needed to inform policy decisions on the 

 role of rapid diagnostic tests in the clinical management of 

 acute febrile illnesses, with a view to controlling the rise of 

 antimicrobial resistance in LMICs. TRIAL REGISTRATION: 

 Clinicaltrials.gov NCT04081051 . Registered on 6 September 2019. 

 Protocol version 1.4 dated 20 December 2019.},

keywords = {Antibiotic prescription; Antimicrobial resistance; Febrile   illness; Outpatient fever management; Randomized controlled   trial},

pubstate = {published},

tppubtype = {article}

}