Lucinde Ruth, Abdi Abdirahman, Orindi Benedict, Mwakio Stella, Gathuri Henry, Onyango Edwin, Chira Salome, Ogero Morris, Isaaka Lynda, Shangala Jimmy, Oginga Irene Njeri, Wachira Alvin, Manuthu Evans, Kariuki Hazel, Nyikuli Jared, Wekesa Cyprian, Otedo Amos, Bosire Hannah, Okoth Steve Biko, Ongalo Winston, Mukabi David, Lusamba Wilber, Muthui Beatrice, Kirui Nicholas, Adembesa Isaac, Mithi Caroline, Sood Mohammed, Ahmed Nadia, Gituma Bernard, Ongaki Vera Bina, Giabe Matiko, Omondi Charles, Ombajo Loice Achieng, Kagucia Wangeci, English Mike, Hamaluba Mainga, Ochola-Oyier Lynette Isabella, Kamuya Dorcas, Bejon Philip, Agweyu Ambrose, Akech Samuel, Etyang Anthony Oliwa
KEMRI-Wellcome Trust Research Programme (KWTRP) Centre for Geographic Medical Research - Coast (CGMRC), Kilifi, Kenya.
Medicine, Kiambu Level Five Hospital, Kiambu, Kenya.
Wellcome Open Res. 2025 May 28;7:269. doi: 10.12688/wellcomeopenres.18401.2. eCollection 2022.
Mortality among adults admitted to hospital with community acquired pneumonia in resource-limited settings is high. Recent studies conducted in high-income settings have demonstrated beneficial effects of low-dose corticosteroids in reducing mortality in patients with severe community acquired pneumonia. It is unknown whether these findings apply to low-income settings such as sub-Saharan Africa.This pragmatic randomized-controlled open-label trial will determine the effect of adjunctive low-dose corticosteroids in the management of adults admitted to hospital with community acquired pneumonia on mortality 30-days post-randomization.
We will enroll and randomize 2180 patients admitted with a diagnosis of community acquired pneumonia into two arms: the control and intervention arm. Those in the control arm will receive standard care for the treatment of community acquired pneumonia i.e., combination therapy with a beta-lactam and macrolide antibiotic. Those in the intervention arm will receive up to 10-days treatment with low-dose oral corticosteroids in addition to standard care. All participants will be followed up to 30- days post randomization and their final status recorded (alive or dead).
If adjunctive low-dose oral corticosteroids are found to be beneficial, this easily scalable intervention would significantly reduce the currently high mortality associated with community acquired pneumonia.Pan-African Clinical Trials Registry: PACTR202111481740832; ISRCTRN registry: ISRCTN36138594.
在资源有限的环境中,因社区获得性肺炎住院的成年人死亡率很高。近期在高收入环境中进行的研究表明,低剂量皮质类固醇对降低重症社区获得性肺炎患者的死亡率有有益影响。尚不清楚这些研究结果是否适用于撒哈拉以南非洲等低收入环境。这项实用的随机对照开放标签试验将确定辅助低剂量皮质类固醇对因社区获得性肺炎住院的成年人在随机分组后30天死亡率的影响。
我们将招募2180名诊断为社区获得性肺炎的患者并将其随机分为两组:对照组和干预组。对照组患者将接受社区获得性肺炎的标准治疗,即β-内酰胺类和大环内酯类抗生素联合治疗。干预组患者除接受标准治疗外,还将接受长达10天的低剂量口服皮质类固醇治疗。所有参与者将在随机分组后随访30天,并记录其最终状态(存活或死亡)。
如果发现辅助低剂量口服皮质类固醇有益,这种易于扩展的干预措施将显著降低目前与社区获得性肺炎相关的高死亡率。泛非临床试验注册中心:PACTR202111481740832;国际标准随机对照试验编号注册中心:ISRCTN36138594。