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Table 1 Definitions for severe or invasive infections in ZIPS study

From: Zinc for Infection Prevention in Sickle Cell Anemia (ZIPS): study protocol for a randomized placebo-controlled trial in Ugandan children with sickle cell anemia

InfectionDefinition
AbscessOpaque, fluid-filled/fluctuant collection on skin (with purulent discharge if drained)
BacteremiaChildren with a positive blood culture with a true pathogen (e.g., S. aureus, S. pneumoniae, Salmonella, other Gram-negative infections)
CellulitisArea of reddened, warm skin in a child with a history of fever or measured axillary temperature of ≥ 37.5 °C
DiarrheaMore than three loose stools in a 24-h period
DysenteryFever with bloody stools
MalariaMeasured fever (axillary temperature ≥ 37.5 °C) or fever by history and Plasmodium species infection on blood smear
Meningitis/encephalitisFever with 1) nuchal rigidity or altered mental status and 2) CSF with > 5 WBC or with positive CSF culture for meningitis-associated organisms (e.g., S. pneumoniae, N. meningiditis, H. influenzae)
OsteomyelitisFever with bone pain, redness of skin over bone and x-ray findings consistent with osteomyelitis
Pharyngitis/tonsillitisInflamed, erythematous pharynx and/or tonsils, with pharyngeal or tonsillar exudates
Pneumonia/acute chest syndrome (ACS)Clinical syndrome characterized by a new pulmonary infiltrate and at least three of the following: chest pain, temperature greater than 38.5C, tachypnea, wheezing, or cough
Children who have three or more of the above symptoms/signs must get a chest x-ray*
SepsisMeets modified criteria for SIRS/sepsis in International pediatric sepsis consensus guidelines (two or more of the following criteria, one of which must be abnormal temperature: T ≥ 38.5 °C, age-specific tachycardia, age-specific tachypnea, age-specific leukopenia)
Modified to remove leukocytosis because, per NOHARM study data, > 80% of children with SCA at Mulago Hospital will have age-specific leukocytosis at baseline, which is an IPSC criterion for SIRS/sepsis. Since SIRS in a child with SCA is always suspected to be due to infection, we will use the term sepsis
Sinusitis (acute)Congestion, nasal discharge or cough for more than 10 days without improvement; or symptoms of congestion with purulent nasal discharge for more than 3 days
Urinary tract infectionSymptoms (fever with urinary frequency, burning or new incontinence after prior toilet training) plus urinalysis positive for LE or nitrite OR clean catch urine culture with > 100,000 colonies of a single pathogen
  1. *Any child with a standard clinical diagnosis of pneumonia (clinical signs above) will be treated for pneumonia regardless of CXR findings, as this is Nalufenya Sickle Cell Clinic protocol. Chest x-rays will be read by an on-call radiologist for acute clinical care, and also saved for reading by a second radiologist. Specific criteria will be assessed by both radiologists, and only children who meet criteria from the WHO Radiology Working Group for pneumonia will be given a final diagnosis of pneumonia (Cherian T et al., Bulletin of WHO, 2005;83:353–359). Children who do not meet radiographic criteria will be given a final diagnosis of “respiratory infection” and not included in primary category of “severe or invasive infections” that constitutes the primary study endpoint. They will be considered for the secondary endpoint of “all clinical infections”. CSF cerebrospinal fluid, IPSC International Pediatric Sepsis Consensus, LE leukocyte esterase, SIRS systemic inflammatory response syndrome, WBC white blood cells