Malaria study - bulaquine versus primaquine
| ISRCTN | ISRCTN50134587 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50134587 |
| Protocol serial number | N/A |
| Sponsor | Indian Council of Medical Research |
| Funder | The project was undertaken as part of the Indian Council of Medical Research centre for Advanced Research in Clinical Pharmacology at the department of clinical pharmacology, Seth GS Medical College & KEM Hospital, Mumbai, India |
- Submission date
- 23/02/2006
- Registration date
- 03/03/2006
- Last edited
- 13/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Nilima Kshirsagar
Scientific
Scientific
Dean, Professor and Head
Department of Clinical Pharmacology
Seth GS Medical College and KEM Hospital
Parel, A Donde Marg
Mumbai
400012
India
| Phone | +91 (0)22 24131419 |
|---|---|
| dcpkem@vsnl.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, parallel group |
| Secondary study design | Randomised controlled trial |
| Scientific title | Malaria study - bulaquine versus primaquine |
| Study acronym | BQ vs PQ |
| Study objectives | To assess whether bulaquine has superior gametocytocidal activity versus primaquine for Plasmodium falciparum malaria |
| Ethics approval(s) | Yes, protocol approved by the Ethics Committee of the Seth GS Medical College and KEM Hospital, Mumbai, India |
| Health condition(s) or problem(s) studied | Uncomplicated P. falciparum malaria |
| Intervention | Patients are randomised to receive either one of two gametocytocidal drugs: bulaquine 75 mg or primaquine 45 mg |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Bulaquine, primaquine |
| Primary outcome measure(s) |
Gametocytemia at days 8, 15, 22 and 29 of follow-up |
| Key secondary outcome measure(s) |
Gametocyte viability at days 8, 15, 22 and 29 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 93 |
| Key inclusion criteria | 1. Aged more than 16 years 2. Uncomplicated Plasmodium falciparum malaria 3. Gametocyte count more than 55 /ul within 72 hours of diagnosis, irrespective of asexual parasitemia 4. Willing to give written, informed consent |
| Key exclusion criteria | 1. Pregnancy 2. Lactation 3. Allergy to primaquine or bulaquine 4. Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency 5. Co-infection with Plasmodium vivax |
| Date of first enrolment | 01/06/2003 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- India
Study participating centre
Not provided at time of registration
Dean, Professor and Head
Mumbai
400012
India
Mumbai
400012
India
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2006 | Yes | No | |
| Other publications | 01/12/2006 | Yes | No |
Editorial Notes
13/09/2017: internal review.
