Safety and Efficacy of miltefosine alone and in combination with sodium stibogluconate and liposomal amphotericin B for the treatment of primary visceral leishmaniasis in East Africa: study protocol for a randomized controlled trial
2011

Study on Treatments for Visceral Leishmaniasis in East Africa

Sample size: 189 publication 10 minutes Evidence: moderate

Author Information

Author(s): Omollo Raymond, Alexander Neal, Edwards Tansy, Khalil Eltahir AG, Younis Brima M, Abuzaid Abuzaid A, Wasunna Monique, Njoroge Njenga, Kinoti Dedan, Kirigi George, Dorlo Thomas PC, Ellis Sally, Balasegaram Manica, Musa Ahmed M

Primary Institution: Drugs for Neglected Diseases initiative (DNDi) Africa, Centre for Clinical Research, Kenya Medical Research Institute

Hypothesis

Can miltefosine alone or in combination with other drugs effectively treat primary visceral leishmaniasis in East Africa?

Conclusion

The study aims to identify effective treatment regimens for visceral leishmaniasis that are both safe and cost-effective.

Supporting Evidence

  • Visceral leishmaniasis is fatal if left untreated.
  • Current treatments are costly and have significant side effects.
  • Miltefosine has shown promising results in previous studies.

Takeaway

This study is trying to find the best way to treat a serious disease called visceral leishmaniasis using different medicines.

Methodology

A phase II randomized controlled trial comparing three treatment regimens for visceral leishmaniasis.

Potential Biases

Possible bias in patient selection and treatment allocation.

Limitations

Limited experience with miltefosine in the region and potential geographical differences in drug response.

Participant Demographics

Patients aged 7 to 60 years with confirmed visceral leishmaniasis.

Statistical Information

P-Value

p<0.05

Statistical Significance

p<0.05

Digital Object Identifier (DOI)

10.1186/1745-6215-12-166

Want to read the original?

Access the complete publication on the publisher's website

View Original Publication