Evaluation of the adverse events following immunization surveillance system in Guruve district, Mashonaland Central 2017

Introduction: an adverse event following immunisation is any untoward medical occurrence which follows vaccination. Frequency of adverse events ranges from 13% to 34% and they should be reported regardless of severity. From the beginning of 2016 to mid-2017, Guruve district in Zimbabwe did not report any AEFIs. This suggests the surveillance system may be failing to detect adverse events. We therefore evaluated the AEFI surveillance system in Guruve district. Methods: we conducted a surveillance system evaluation using the updated Centers for Disease Control guidelines for evaluating public health surveillance systems. We interviewed health workers and caregivers of babies under 2 years in Guruve district. We also reviewed all records on AEFI surveillance for the period of January 2016 to November 2017. Results: we recruited 31 health workers and 33 caregivers into the study. Between January 2016 and mid-2017, 39% of the caregivers had children who had suffered AEFIs and 45% of the health workers had encountered AEFIs but none had been notified. The main reasons for failure to report AEFIs included health workers' fear of personal consequences and caregivers thinking that an adverse event was not serious enough to report. Knowledge of the surveillance system was good amongst the majority of health workers. All the resources needed by the surveillance system were available. Conclusion: we concluded that health workers in Guruve district were afraid to report adverse events following immunization and caregivers were reluctant to report mild adverse events hence the surveillance system was performing poorly and was not useful. However, the stability of the system and the good knowledge gives a good foundation for improving the surveillance system

Single-Dose Liposomal Amphotericin B Treatment for Cryptococcal Meningitis.

BackgroundCryptococcal meningitis is a leading cause of human immunodeficiency virus (HIV)-related death in sub-Saharan Africa. Whether a treatment regimen that includes a single high dose of liposomal amphotericin B would be efficacious is not known.MethodsIn this phase 3 randomized, controlled, noninferiority trial conducted in five African countries, we assigned HIV-positive adults with cryptococcal meningitis in a 1:1 ratio to receive either a single high dose of liposomal amphotericin B (10 mg per kilogram of body weight) on day 1 plus 14 days of flucytosine (100 mg per kilogram per day) and fluconazole (1200 mg per day) or the current World Health Organization-recommended treatment, which includes amphotericin B deoxycholate (1 mg per kilogram per day) plus flucytosine (100 mg per kilogram per day) for 7 days, followed by fluconazole (1200 mg per day) for 7 days (control). The primary end point was death from any cause at 10 weeks; the trial was powered to show noninferiority at a 10-percentage-point margin.ResultsA total of 844 participants underwent randomization; 814 were included in the intention-to-treat population. At 10 weeks, deaths were reported in 101 participants (24.8%; 95% confidence interval [CI], 20.7 to 29.3) in the liposomal amphotericin B group and 117 (28.7%; 95% CI, 24.4 to 33.4) in the control group (difference, -3.9 percentage points); the upper boundary of the one-sided 95% confidence interval was 1.2 percentage points (within the noninferiority margin; P10 colony-forming units (CFU) per milliliter per day in the liposomal amphotericin B group and -0.42 log10 CFU per milliliter per day in the control group. Fewer participants had grade 3 or 4 adverse events in the liposomal amphotericin B group than in the control group (50.0% vs. 62.3%).ConclusionsSingle-dose liposomal amphotericin B combined with flucytosine and fluconazole was noninferior to the WHO-recommended treatment for HIV-associated cryptococcal meningitis and was associated with fewer adverse events. (Funded by the European and Developing Countries Clinical Trials Partnership and others; Ambition ISRCTN number, ISRCTN72509687.)