CTRI/2012/08/002891已完成4 期
A Pilot Project To Evaluate The Safety And Effectiveness Of New Treatment Modalities For The Management Of Visceral Leishmaniasis (VL) In The Endemic Regions Of India
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 7,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Primary cases: all â??new casesâ?? with clinical features of VL (fever for 2 weeks and splenomegaly) and are rk39 or parasitology positive.
- •Relapse cases: all cases that have previously been treated for VL (but not involving any one of the drugs that are part of the new treatment modality used at that treatment centre), have fever, splenomegaly and are confirmed by parasitology.
- •Written consent to receive one of the new treatment modalities and allow information to be collected as part of a pilot project.
排除标准
- •Pregnant women and women of child bearing age who cannot be assured contraceptive cover will be excluded from all miltefosine containing regimens. These cases may be referred and managed with non-miltefosine new treatment modalities in the nearest district hospital/ designated referral centre. Their exclusion will be recorded within the surveillance register.
- •All patients who have previously been treated with one of the drugs that are part of the new treatment modality in use at that centre will be excluded (e.g. any patient treated with miltefosine monotherapy will not be retreated with a miltefosine combination treatment; any patient treated with high dose AmBisome® will not be given single dose AmBisome® or an AmBisome® combination). Their admission will however be recorded within the surveillance register.
- •All known HIV+ patients (see special cases below) patients will be treated with alternative regimens. Their admission will however be recorded within the surveillance register.
- •All PKDL patients will be treated with alternative regimens. Their admission will however be recorded within the surveillance register.
- •All patients with a history of allergy or hypersensitivity to the relevant drug
- •Special cases
- •A category of special cases will be defined on entry based on the classifications below. These cases will either be managed by specific treatments (e.g. one particular new treatment modality) and/ or in specialist referral centres.
- •All pregnant women can be included and will be treated with AmBisome® 10mg/kg single dose. All pregnant cases treated, or patients given a new treatment modality and who become pregnant within one month of end of treatment will be entered into a special pregnancy follow up register.
- •All women of child bearing age who cannot be assured contraceptive cover will be treated with either AmBisome® & paromomycin or AmBisome® single dose.
- •All patients with signs and symptoms of severe diseases: defined as severe anaemia (i.e. haemoglobin 4 and/ or signs of cardiac failure), renal failure or hepatic failure (e.g. jaundice), serious concomitant infection (e.g. severe pneumonia), severe malnutrition, will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physicianâ??s decision.
- •All patients with proven TB/VL co-infection will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physicianâ??s decision.
- •All children under 2 will be referred to the nearest district hospital or RMRIMS for further specialist management. These patients may be treated with one of the new treatment modalities according to the physicianâ??s decision.
- •Note: All patients with proven HIV/ VL co-infection will also be referred to the nearest district hospital or RMRIMS for further specialist management. However, as defined in the exclusion criteria, these patients will not be treated with one of the new treatment modalities. Compassionate high dose therapy with AmBisome® or a high dose combination of drugs may be used according to the physicianâ??s decision.
- •All consenting patients entering a centre where one of the new treatment modalities is being piloted will be entered in to a register. All
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