BackgroundChildren are most vulnerable to malaria. A pyronaridine-artesunate pediatric granule formulation is being developed for the treatment of uncomplicated Plasmodium falciparum malaria.MethodsThis phase III, multi-center, comparative, open-label, parallel-group, controlled clinical trial included patients aged ≤12 years, bodyweight ≥5 to <25 kg, with a reported history of fever at inclusion or in the previous 24 h and microscopically-confirmed uncomplicated P. falciparum malaria. Patients were randomized (2:1) to pyronaridine-artesunate granules (60/20 mg) once daily or artemether-lumefantrine crushed tablets (20/120 mg) twice daily, both dosed by bodyweight, orally (liquid suspension) for three days.ResultsOf 535 patients randomized, 355 received pyronaridine-artesunate and 180 received artemether-lumefantrine. Day-28 adequate clinical and parasitological response (ACPR), corrected for re-infection using polymerase chain reaction (PCR) genotyping (per-protocol population) was 97.1% (329/339; 95% CI 94.6, 98.6) for pyronaridine-artesunate; 98.8% (165/167; 95% CI 95.7, 99.9) for artemether-lumefantrine. The primary endpoint was achieved: pyronaridine-artesunate PCR-corrected day-28 ACPR was statistically significantly >90% (P < .0001). Pyronaridine-artesunate was non-inferior to artemether-lumefantrine: treatment difference -1.8% (95% CI -4.3 to 1.6). The incidence of drug-related adverse events was 37.2% (132/355) with pyronaridine-artesunate, 44.4% (80/180) with artemether-lumefantrine. Clinical biochemistry results showed similar mean changes versus baseline in the two treatment groups. From day 3 until study completion, one patient in each treatment group had peak alanine aminotransferase (ALT) >3 times the upper limit of normal (ULN) and peak total bilirubin >2xULN (i.e. within the Hy’s law definition).ConclusionsThe pyronaridine-artesunate pediatric granule formulation was efficacious and was non-inferior to artemether-lumefantrine. The adverse event profile was similar for the two comparators. Pyronaridine-artesunate should be considered for inclusion in paediatric malaria treatment programmes.Trial registrationClinicalTrials.gov: identifier NCT00541385
Childhood tuberculosis (TB) is a diagnostic challenge in developing countries, and patient outcome can be influenced by certain factors. We report the disease course, clinical profile and factors associated with treatment outcome in a tertiary facility of Kinshasa. Documentary and analytical studies were conducted using clinical and exploratory data for children aged up to 15 years who were admitted to the University Clinics of Kinshasa for TB. Data are presented as frequencies and averages, and binary and logistic regression analyses were performed. Of 283 children with TB, 82 (29.0%) had smear-negative TB, 40 (14.1%) had smear-positive TB, 159 (56.1%) had extra-pulmonary TB (EPTB), 2 (0.7%) had multidrug-resistant TB (MDR-TB), 167 (59.0%) completed treatment, 30 (10.6%) were cured, 7 (2.5%) failed treatment, 4 (1.4%) died, 55 (19.4%) were transferred to health centers nearest their home, and 20 (7.0%) were defaulters. In the binary analysis, reported TB contacts (p = 0.048), type of TB (p = 0.000), HIV status (p = 0.050), Ziehl-Nielsen test result (p = 0.000), Lowenstein culture (p = 0.004) and chest X-ray (p = 0.057) were associated with outcome. In the logistic regression, none of these factors was a significant predictor of outcome. Tertiary level care facilities must improve the diagnosis and care of patients with childhood TB, which justifies the development of alternative diagnostic techniques and the assessment of other factors that potentially affect outcome.
Objective To assess the content and delivery of essential antenatal services before implementation of programmes for prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV). Methods We assessed 18 antenatal care centres (eight public units and ten managed by nongovernmental organizations) in Kinshasa, Democratic Republic of the Congo. We used a survey to capture information about the number and type of antenatal health workers, infrastructure capacity and the delivery of basic antenatal care services such as: nutritional counselling; tetanus toxoid vaccination; prevention and management of anaemia, malaria, sexually transmitted infections, and tuberculosis; and counselling for postpartum contraception. Findings Antenatal care units differed with respect to size, capacity, cost, service delivery systems and content. For instance, 17 of the 18 sites offered anaemia screening but only two sites included the cost in the card that gives access to antenatal care. Nine of the clinics (50%) reported providing the malaria prophyalxis sulfadoxine pyrimethamine as per national policy. Four (22%) of the sites offered syphilis screening. Conclusion Scaling up PMTCT programmes in under-resourced settings requires evaluation and strengthening of existing basic antenatal care service delivery. IntroductionAt the end of 2005, an estimated 38.6 million people were living with human immunodeficiency virus (HIV). Nearly two-thirds of these were in sub-Saharan Africa 1,2 where countries struggling to respond to the crisis are simultaneously battling poverty, poor infrastructure, competing health needs and, in some cases, civil unrest. In 2004, women represented 57% of all cases of HIV in sub-Saharan Africa and made up nearly three-quarters of new infections in the 15-24 years age group in the region. Approximately 700 000 children younger than 15 years were newly in--fected with the virus in 2005.1 Almost 90% of these newly infected children were born to HIV-infected mothers and acquired HIV during pregnancy, labour and delivery, or via breastfeeding. 1,3,4 Interventions to reduce the transmission
Since 2015, the Democratic Republic of Congo has subscribed to the global goal of eliminating HIV / AIDS as a major public health problem by 2030. However, there is a lack of evidence on the current level of key indicators of the epidemic in the country. In another hand, no study has yet explored the extent to which the country could meet the 2030 target. This study aimed to: (i) determine the current level of key indicators of the HIV / AIDS epidemic in the DRC; and (ii) assess whether the DRC could achieve the goal of eliminating HIV / AIDS as a major public health problem by the end of 2030. For the country as a whole and for 24 of its 26 provinces, we performed: (1) a trend analysis of HIV / AIDS surveillance data; and (2) projections of key indicators of the epidemic by 2030 on Spectrum software. In 2017, the DRC is experiencing a generalized epidemic of HIV / AIDS (national prevalence of 1.0%, 97.5%CI: 0.85% -1.14%), which is poorly expansive (national incidence of 6, 97, 5%IC: 5 -7 new infections per 10 000 person-years of observation). Ten of its 26 provinces have so far experienced a concentrated epidemic. From 2017 to 2030, HIV prevalence will decline for the country as a whole, falling below 1% by 2018 and reaching 0.76% by 2030. The incidence will experience the same overall declining trend. Nine provinces appear to be driving the epidemic. The DRC should target intensively the nine driving provinces of the epidemic and some of its key determinants, in order to fulfill the goal of reducing the HIV / AIDS epidemic to a non-major public health concern by 2030.
Introduction Neonates with serious bacterial infections should be treated with injectable antibiotics after hospitalization, which may not be feasible in many low resource settings. In 2015, the World Health Organization (WHO) launched a guideline for the management of young infants (0–59 days old) with possible serious bacterial infection (PSBI) when referral for hospital treatment is not feasible. We evaluated the feasibility of the WHO guideline implementation in the Democratic Republic of the Congo (DRC) to achieve high coverage of PSBI treatment. Methods From April 2016 to March 2017, in a longitudinal, descriptive, mixed methods implementation research study, we implemented WHO PSBI guideline for sick young infants (0–59 dyas of age) in the public health programme setting in five health areas of North and South Ubangi Provinces with an overall population of about 60,000. We conducted policy dialogue with national and sub-national level government planners, decision-makers, academics and other stakeholders. We established a Technical Support Unit to provide implementation support. We built the capacity of health workers and managers and ensured the availability of necessary medicines and commodities. We followed infants with PSBI signs up to 14 days. The research team systematically collected data on adherence to treatment and outcomes. Results We identified 3050 live births and 285 (9.3%) young infants with signs of PSBI in the study area, of whom 256 were treated. Published data have reported 10% PSBI incidence rate in young infants. Therefore, the estimated coverage of treatment was 83.9% (256/305). Another 426 from outside the study catchment area were also identified with PSBI signs by the nurses of a health centre within the study area. Thus, a total of 711 young infants with PSBI were identified, 285 (40%) 7–59 days old infants had fast breathing (pneumonia), 141 (20%) 0–6 days old had fast breathing (severe pneumonia), 233 (33%) had signs of clinical severe infection (CSI), and 52 (7%) had signs of critical illness. Referral to a hospital was advised to 426 (60%) infants with CSI, critical illness or severe pneumonia. The referral was refused by 282 families who accepted simplified antibiotic treatment on an outpatient basis at the health centres. Treatment failure among those who received outpatient treatment occurred in 10/128 (8%) with severe pneumonia, 25/147 (17%) with CSI, including one death, and 2/7 (29%) young infants with a critical illness. Among 285 infants with pneumonia, 257 (90%) received oral amoxicillin treatment, and 8 (3%) failed treatment. Adherence to outpatient treatment was 98% to 100% for various PSBI sub-categories. Among 144 infants treated in a hospital, 8% (1/13) with severe pneumonia, 23% (20/86) with CSI and 40% (18/45) with critical illness died. Conclusion Implementation of the WHO PSBI guideline when a referral was not possible was feasible in our context with high coverage. Without financial and technical input to strengthen the health system at all levels, including the community and the referral level, it may not be possible to achieve and sustain the same high treatment coverage.
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