5 mg) to loose (L) AS (50 mg) +AQ (153 mg) in 750, P. falciparum-infected children from Burkina Faso aged 6 months to 5 years. Dosing was by age. Primary efficacy endpoint
was Day (D) 28, PCR-corrected, parasitological cure rate. Recipients of rescue treatment were counted as failures and new infections as cured. Documented, EVP4593 supplier common toxicity criteria (CTC) graded adverse events (AEs) defined safety.
Results: Recruited and evaluable children numbered 750 (375/arm) and 682 (90.9%), respectively. There were 8 (AS/AQ) and 6 (AS+AQ) early treatment failures and one D7 failure (AS+AQ). Sixteen (AS/AQ) and 12 (AS+AQ) patients had recurrent parasitaemia (PCR new infections 10 and 6, respectively). Fourteen patients per arm required rescue treatment for vomiting/spitting out study drugs. see more Efficacy rates were 92.1% in both arms: AS/AQ = 315/342 (95% CI: 88.7-94.7) vs. AS+AQ = 313/340 (95% CI: 88.6-94.7). Non-inferiority was demonstrated at two-sided alpha = 0.05: Delta(AS+AQ-AS/AQ) = 0.0% (95% CI: -4.1% to 4.0%). D28, Kaplan Meier PCR-corrected cure rates (all randomized children) were similar: 93.7% (AS/AQ) vs. 93.2% (AS+AQ) Delta = -0.5 (95% CI -4.2 to 3.0%). By D2, both arms had rapid parasite (F & L, 97.8% aparasitaemic) and fever (97.2% [F], 96.0% [L] afebrile) clearances.
Both treatments
were well tolerated. Drug-induced vomiting numbered 8/375 (2.1%) and 6/375 (1.6%) in the fixed and loose arms, respectively (p = 0.59). One patient developed asymptomatic, CTC grade 4 hepatitis (AST 1052, ALT 936). Technical difficulties precluded the assessment and risk of neutropaenia for all patients.
Conclusion: Fixed dose
AS/AQ was efficacious and well tolerated. These data support the use of this new fixed dose combination for treating P. falciparum malaria with continued safety monitoring.”
“Background: Heterotopic ossification following lower-limb joint arthroplasty is a challenging clinical problem. No comprehensive study has been conducted on heterotopic ossification after total ankle arthroplasty, to our knowledge. The purpose of this study was to evaluate selleck chemicals the prevalence and location of heterotopic ossification after primary total ankle arthroplasty, predisposing factors, and effects on clinical outcomes, and to develop a method of classification.
Methods: Eighty ankles in eighty patients with a primary total ankle arthroplasty were followed for a mean (and standard deviation) of 31.9 +/- 11.3 months (range, twenty-four to sixty-five months). The prevalence and location of heterotopic ossification, predisposing factors, and outcomes were analyzed, and a method of classification was developed.
Results: Twenty (25%) of the eighty ankles demonstrated postoperative heterotopic ossification, with the majority of the cases in the posterior aspect of the ankle.